PROYECTO DE INGENIERÍA CLINICA I1

/“BASE DE DATOS PARA LA IMPLEMENTACIÓN DE PROGRAMAS DE MANTENIMIENTO A EQUIPO MÉDICO”

“BIPMED”

ASESORES:

DR. Fernando Prieto “HOSPITAL GENERAL DE MÉXICO??

M.en I. Miguel A. Peña “ UNIVERSIDAD AUTONOMA METROPOLITANA” Ing. Rocío Pedroza “ UNIVERSIDAD AUTONOMA METROPOLITANA”

/ ALUMNO:

Ricardo Santiago G.o%c 2

/

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OBJETIVO GENERAL:

Crear una base de datos que sirva de consulta para la elaboración de programas de mantenimiento preventivo a equipo médico.

La base se desarrollará en un programa de lenguaje C++.

OBJETIVOS PARTICULARES:

1 ..- Recabar información concerniente a problemas más comunes que se presentan en el equipo médico y sus repercusiones en el paciente o en el operador.

1 . l . La investigación se basara en la información que se logre obtener de la FOOD AND DRUG ADMINISTRATION por medio del programa de observación de equipo médico llamado Clinical Impact of Adverse Reporting (MEDWATCH).

1.2.- Generar un programa de software donde se planteen los cuestionamientos más importantes que describen las características de implementación, operación y funcionamiento de los equipos médicos que se encuentran en un hospital.

1.3.- Establecer una clasificación de prioridades de mantenimiento preventivo de equipos médicos de acuerdo con las consecuencias que provocarían una falla en su funcionamiento.

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La necesidad de desarrollar e implementar regularmente programas de inspección y mantenimiento preventivo para equipo electrónico que se utilice para el cuidado del paciente en cualquier ámbito, ha venido desarrollándose y creciendo en los últimos años en México. Esta tendencia, ha ayudado a disminuir de forma muy significativa las consecuencias de falla de algún equipo médico, tales como: Daño al paciente u Operador, Alto costo de reparación, Perdida de tiempo para el Médico/Hospital, Incomodidad para el paciente, Inutilización del equipo etc.

The Food and Drugs Administration ha recopilado información sobre los problemas más frecuentes y sus consecuencias en todos los hospitales de los estados Unidos de Norte América, con toda esta información se pueden generar programas de mantenimiento preventivo a equipo electrónico relacionado directa o indirectamente con el cuidado del paciente, con el objetivo de proveer seguridad al paciente y operador además del máximo desempeño del equipo. Esta información requiere ser analizada para que se apliquen y desarrollen planes para cada equipo en inspección y mantenimiento; esto creando clasificaciones de prioridad y uso.

En el contexto hospitalario moderno no se puede concebir un hospital sin un departamento de Ingeniería Biomédica, el cual es responsable del mantenimiento preventivo, inspección calibración y apoyo médico del total del equipo médico en el hospital, además de muchas otras funciones; Por lo tanto el Ingeniero Biomédico debe ser capaz de evaluar el estado en general del equipo que se le asigne y realizar un programa de revisión periódica, mantenimiento preventivo, calibración y reparación si las circunstancias' lo permiten.

Este programa además de intentar facilitar la implementación de programas de mantenimiento, plantea servir como consulta para Ingenieros Biomédicos, Ingenieros Electrónicos o estudiantes que requieran de corroborar sus planes 0 programas de mantenimiento, sin pretender hasta este momento convertirse en la etapa decisiva del programa de mantenimiento indispensable en el hospital.

' Saber en que términos está el equipo en el hospital: Compra (garantía), Comodato, Donación, Contrato, etc. 3

ANTECEDENTES:

En Mayo de 1974 en el Miami Heart Institute se implantó por primera vez un programa de software dirigido especialmente para implementar programas de mantenimiento al equipo médico que se encontraba en el Hospital. Este programa permitía realizar consultas computarizadas dentro de la rutina de inspección y mantenimiento preventivo, ayudando así a lograr cuando fuera necesario las calibraciones y reparaciones de los equipos de diagnóstico, de laboratorio o de tratamiento que de alguna manera tuviera contacto con el paciente. La idea de automatizar de alguna manera los programas de mantenimiento, surge a raíz de los numerosos casos que en ese entonces ocurrían de electrocución por equipos médicos, en pacientes que dependían del equipo o que solo recibían cierto soporte. El programa fue desarrollado por un grupo interdisciplinario de profesionistas encabezado por el departamento de Ingeniería Biomédica y soportado por la División de Servicio de Cómputo del Hospital, quienes en 1973 idearon la manera de implementar un servicio que facilitara la toma de decisiones en el servicio y la calendarización de los mantenimientos. Debido a que la idea surgió después de los casos de muerte de pacientes por electrocución, se puso especial énfasis en la seguridad eléctrica de todos los equipos, resaltando la importancia de la tierra fisica y su instalación (grounding systems).

El Servicio de Cómputo del Hospital de Miami instalo en línea 100 estaciones para consultar el programa a través de toda la institución y dos estaciones remotas más en otros hospitales de Miami.

El sistema que se utilizó fue una Computadora Xerox Sigma 9 (con microprocesador de mediana escala) con 128 K de memoria y la plataforma de lenguaje fue el llamado meta-assembler. Debido a la novedad y eficiencia que proporcionaba el sistema, muchos de los operadores del equipo, médicos y enfermeras contribuían con noticias e información para cada vez ir mejorando más la base de datos, y por lo tanto disminuyendo los posibles errores o aminorando la posibilidad de falla por falta de mantenimiento.

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El proyecto siguiente no es una copia del caso anterior sino una manera de complementar y de encausar la información recopilada hasta el momento por la FDA que se describe adelante.

Como es bien sabido por las personas involucradas en el mantenimiento a equipo médico, no resulta siempre fácil el llevar a cabo un plan de mantenimiento, por algunas de las siguientes razones:

a) ¿ Que equipo es más importante y porque ?

b) ¿ Que aplicación requiere una mayor prioridad en el servicio ?

c) ¿ Como diferenciar en el riesgo que tiene un equipo de otro y porque ?

Las preguntas anteriores son solo una muestra de las muchas que un Ingeniero Biomédico se debe hacer y contestar para elaborar un plan de mantenimiento a los equipos con los que cuente en el hospital.

Por lo anterior se recopilará la información que servirá como base para el planteamiento de las preguntas ( más comunes ) en un cuestionario, mismo que solo tiene la finalidad (por el momento) de servir como apoyo en la toma de decisiones y en un futuro como una consulta 299 % confiable del tipo de mantenimiento y las recomendaciones de seguridad eléctrica y de operación de cada equipo que se consulte.

El 1% de la decisión corresponderá al usuario quien será el responsable siempre el criterio final. 5

CONFORMACIóN DEL PROGRAMA:

Se utilizará un paquete de programación de “C++” para la creación de la base de datos, con la estructura siguiente.

MENU PRINCIPAL

1 .- NUEVA CONSULTA

2.- BORRAR CONSULTA

3.- CONSULTA POR EQUIPO

4.- TEXTOS DE REFERENCIA

5.- SALIR DEL PROGRAMA

El menú principal consta de 5 opciones que se describirán con detalle en los siguientes párrafos.

Comenzaremos con la parte medular del programa que es la consulta del cuestionario llamada NUEVA CONSULTA marcada con el número 1; Cuando se selecciona la NUEVA CONSULTA se entra inmediatamente a la sección de preguntas, son 13 cuestionamientos que el usuario debe responder uno a uno para que se pueda avanzar a la siguiente pregunta, en esta parte del programa no es posible salir sin haber terminado de contestar las preguntas.

La segunda opción se refiere a ELIMINAR UNA CONSULTA que previamente ya se haya registrado, el punto clave por el que se manejan estos archivos es una cadena de dígitos la cual hay que asignar de manera única para cada equipo. Este procedimiento se describirá con detalle al final del cuestionario (nueva consulta). En el caso de que la clave que se proporcione no este dentro de los arreglos guardados en el programa, se recibirá un mensaje diciendo que la “clave no existe”, en caso contrario el programa borra la clave y regresa al menú principal.

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3.- CONSULTA POR EQUIPO.- Entrando a esta opción se puede visualizar la sugerencia de mantenimiento para cada equipo que previamente se haya guardado, solo hay que proporcionar la clave única del equipo.

Cuando la clave que se proporcione este dentro de los archivos del programa, se desplegará automáticamente una pantalla con la CLAVE DEL EQUIPO, el NOMBRE DEL EQUIPO y su sugerencia de mantenimiento.

Si la clave que se introdujo no está dentro de los archivos, se mostrará un mensaje como el siguiente "LA CLAVE NO EXISTE, PULSE ENTER "

4.- Los textos de referencia son archivos en los que se fimdamentan las preguntas y respuestas del cuestionario, todo en base a la información que se obtuvo del programa MEDWATCH que auspicia la FOOD AND DRUG ADMINISTRATION en los Estados Unidos de Norteamérica.

Estos archivos son recopilaciones que se hicieron de las fallas más frecuentes en los equipos médicos, algunas de las causas, la localización de cada equipo dentro del hospital, información del fabricante y su localización.

Los expedientes de los que consta el MEDWATCH comienzan desde el año de 1984 y están actualizados hasta 1997, la cantidad de información se mide en MB (mega bytes) y es alrededor de 800 MB lo cual es un mundo de información, por lo tanto para poder formular las preguntas del cuestionario se eligieron los dos primeros años y los dos más recientes para poder analizar 30 casos de cada año y sugerir algunas respuestas; por lo tanto se cuenta con 120 informes de equipos que fallaron, sus consecuencias, probables causas, ubicación o servicio dentro del hospital y descripción de modelo y fabricante. Las demás preguntas que se formulan son hechas de acuerdo a la información que tiene el Dr, FERNANDO PRIETO del Hospital general de México, trabajo en el que se cimentaron las bases para el programa BIPMED.

La experiencia que se ha tenido en cuanto al mantenimiento preventivo a equipo médico indica que se tienen que tomar algunas decisiones de prioridad para poder administrar el tiempo, los recursos, el personal y lo más importante prevenir una falla que involucre la vida o el bienestar del paciente o el operador. Por lo tanto la decisión final de prioridad y calendarización del mantenimiento se delega al Ingeniero Biomédico a cargo.

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La descripción de cada pregunta se listara a continuación con sus correspondientes opciones de respuesta.

PREGUNTA 1

La falla del equipo tiene como consecuencia:

9.- Riesgo para la vida del paciente o el operador 8.- Riesgo de lesiones para el paciente o el operador 7.- Error en el tratamiento 6.- Error en el diagnóstico 5.- Retraso en el tratamiento 4.- Retraso en el diagnóstico 3 .- Inconveniencia o incomodidad para el paciente 2.- Pérdida económica para el Hospital 1 .- Ninguna de las anteriores.

La pregunta uno se refiere la inmediata consecuencia que tendría el equipo cuando llegase a fallar, esto es uno de los más importantes puntos que se toman en cuenta para la sugerencia de mantenimiento por obvias razones.

PREGUNTA 2

El equipo se encuentra localizado en:

9.- Urgencias 8.- Anestesiología o Cardiología 7.- Radiología o Neurología 6.- Oftalmología o Estomatología 5 .- Quirófanos 4.- Hospitalización 3 .- Urología o Gastroenterología 2.- Medicina externa 1 .- Ninguna de las anteriores

Es importante saber la localización del equipo en el hospital debido a sus requerimientos de uso y necesidades de disponibilidad.

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PREGUNTA 3

Durante su empleo produce o detecta:

9.- Calor 8.- Rayos X 7.- Corriente Eléctrica o Voltaje 6. - Ultrasonido 5.- Láser 4.- Aire o vacío (Flujo Neumático) 3.- Flujo Hidráulico 2.- Presión Mecánica 1 .- Ninguna de las anteriores

La pregunta tres cuestiona que clase de energía produce el equipo en cuestión, se sabe que no solo los equipos médicos producen energía, si no que también la detectan o miden. Esto también es un punto clave en la decisión de prioridad, debido a la clase de energía y la magnitud de ésta el equipo maneje.

PREGUNTA 4

Características de Función del equipo:

9.- Soporte de vida (Ventilador, Maq. de Anest.) 8.- Tratamiento quirúrgico 7.- Tratamiento del enfermo en estado crítico 6.- Tratamiento por medios fisicos 5.- Monitoreo transoperatorio 4.- Monitoreo del enfermo en estado crítico 3 .- Monitoreo de variables fisiológicas 2.- Análisis de laboratorio 1 .- Ninguna de las anteriores

Esta pregunta se incluye para que el usuario seleccione la opción en la que se encuentra el equipo declarando así el evento clínico en el que se aplica con mayor frecuencia.

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PREGUNTA 5

Voltaje que utiliza

8.- Voltaje de línea y baterías 6.- Solo voltaje de línea 5.- Solo baterías 4.- Baterías y adaptador de corriente alterna

PREGUNTA 6

Con cuantos equipos más se cuenta en el área:

9.- Ninguno más 6.- de 1 a 3 3.- de 4 a 6 1 .- Más de 6

Es muy importante para la toma de decisiones en el mantenimiento preventivo, saber si se cuentan con equipos de respaldo en el área de uso y cuantos.

PREGUNTA 7

Frecuencia de uso del equipo:

9.- Diaria 7.- Cada tercer día 5.- Cada Semana 3.- Cada quince días 1 .- Esporádicamente.

Siempre se requiere saber con que frecuencia se utiliza el equipo en el hospital ya que esto es un muy importante indicador de desgaste y factor para que aumente la posibilidad de que se puedan producir fallas.

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PREGUNTA 8

El equipo se encuentra bajo algún programa de mantenimiento:

9.- NO 5.- sí 4.- NO sé

PREGUNTA 9

El equipo tiene accesorios o componentes móviles o remobibles

9.- Si son indispensables 7.- Si son Desechables 5.- NO 3.- NO Sé

El estar consiente de los accesorios y componentes que un equipo tenga es la base para poder eficientizar su funcionamiento. Existe en el mercado equipos en los que los componentes móviles o desplegables son la parte medular del sistema y que sin ellos sería imposible realizar un buen trabajo, por lo tanto se tiene que poner especial atención al cuidado y procuración de mantenimiento de estos equipos y sus accesorios.

PREGUNTA 1 0

Aproximadamente cuantos años de uso tiene el equipo:

9.- 3 años o más 7.- de 1 a 3 años 5.- Menos de 1 año 1.- NO Sé

La antigüedad del equipo en hncionamiento es un indicio de la clase de mantenimiento que debe recibir y también nos debe indicar la obsolecencia que se pueda ir adquiriendo, misma que pudiera repercutir en pérdida de tiempo o costo económico para el hospital por refacciones y mano de obra.

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PREGUNTA 11

Se tienen antecedentes de fallas anteriores:

9.- Sí han dañado totalmente el equipo. 7.- Sí pero no han sido graves 5.- NO 3.- NO Sé

PREGUNTA 12

El equipo es utilizado por personal:

9.- De enfermería 6.- Médico 5 .- Especialista 4.- Técnico 7.- otro

PREGUNTA 1 3

La situación del equipo en el Hospital es la siguiente:

9.- Es propiedad del hospital 7.- Es un préstamo para el hospital 5.- Esta en comodato 1 .- Ninguna de las anteriores.

Esta pregunta se refiere a si el hospital es dueño del equipo, o cualquier otra de las circunstancias por las que el equipo pudiera estar dentro del servicio hospitalario, esto puede definir si el mantenimiento lo debe realizar el hospital o exigir que quien deba hacerlo lo realice con prontitud y eficacia dependiendo de la sugerencia.

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Cuando se termina de elegir la opción en la pregunta 13 inmediatamente se despliega la sugerencia de mantenimiento que se logró para ese equipo en particular.

Al salir de la sugerencia el programa nos pregunta si queremos guardar la consulta. Si elegimos la opción de guardar, debemos de proporcionar un NOMBRE de EQUIPO y UNA CLAVE, esta clave debe ser única para cada equipo, de esta manera podemos identificar cada uno de ellos independientemente de que se llamen igual o sean del mismo modelo.

Una vez que se dio el nombre del equipo y la clave, el programa guarda lo anterior y la sugerencia de mantenimiento respectiva.

En caso de que no se desee guardar la consulta el programa regresa al menú principal, dejando perder toda la información que se logró.

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MlOOl38~12/24/84(SILCON VFL(SILAFILC0N)lDOWCORNlDOW CORNING OPHTHALMICS(4700 COLLEY AVE(NORFOLK(VA123508(SERIOUS I N J U R Y I N A J N A ~ O P H T H A L M I C ~ H P X ~ F I N A L ~ P T HAD RIGHT LENS DISPENSED 7/1/84. LENSES WORN SUCCESSFULLY UNTIL 11/19/84. PT CAME TO DR FOR BLURRY VISION. EVALUATION THAT SHOWED 3+ EDEMA AND CENTRAL ABRASION. ABRASION EXTENDED TO ENDOTHELIAL LAYER CAUSING ENDOTHELIAL AND STROMAL SCARRING. GANTRISIN WAS ADMINISTERED; VISION REDUCED TO 20/50+ WITH SPECTACLES. HEALING OF THE RIGHT EYE IS PROGRESSING. WHEN EYE IS HEALED CONTACT LENSES WILL BE TRIED AGAIN. DOCTOR'S OPINION THAT ABRASION CAUSED BY FOREIGN BODY OR OVERWEAR SYNDROME.~CAUSE UNKNOWN RlOO155~12/27/84(RADIATION PROTECTION APRONIMAVIAMERIMAVIG OF AMERICAITORRANCE ST, PO BOX 5681TORRINGTONICTI [MALFUNCTION( (ALL VARIETIES(RADIOLOGICAL(IWO(PRELIMINARY(APRONS DEVELOP X-RAY LEAKAGE. REPORTING FIRM HAS DOCUMENTS.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. Ml00203112/27/841T.A.R.A. HIPIDEPUYIDEPUY INClPO BOX

09lORTHOPEDICIKWZIPRELIMINARY~THE ARTHROPLASTY FAILED, REVISION SURGERY WAS PERFORMED AND THE PRODUCT WAS REMOVED.lTHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE. M100204~12/27/84~COMPRESSION ROD 300MMISTUADRUGSURGSUPPlSTUARTll STUART PLAZA, DONOHUE & LUXOR ROADS(GREENSBURG(PA(l56Ol~MALFUNCTION~ ICR1980~ORTHOPEDIC~JDN(FINAL/THE ROD HAD BROKEN SOME TIME AFTER THE OPERATION. DR USED TOO MUCH COMPRESSION AND THE ROD EVENTUALLY BROKE. DID NOT RESULT IN DEATH OR SERIOUS INJURY. (SEE FILE) [THE CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE THE USE OF THE DEVICE. R100205(12/27/84~ANGIOSKOP~SIEMENS(SIEMENS~l86 WOOD AVE SOUTH~ISELIN~NJ(0883O~MALFUNCTION~ I (RADIOLOGICALlJAAlFINAL~POTENTIAL SAFETY HAZARD WITH THE SIEMENS ANGIOSKOP. ANGIOSKOP IS A STATIONARY C-ARM UNIT WITH PROVISIONS FOR DIRECT AND INDIRECT RADIOGRAPHIC TECHNIQUES. HAS A DUAL IMAGE RECEPTOR. SELECTION IS DONE MANUALLY BY ROTATING THE RECEPTOR ASSEMBLY 90 DEGREES. IN 1981, FIVE INCIDENTS REPORTED WHERE THE LATCH MECHANISM HAD RELEASED AND CAUSED THE RECEPTOR ASSEMBLY TO ROTATE. ONE PATIENT WAS STRUCK ON THE SIDE OF THE ABDOMEN, UNINJURED. IN 1982, ATTACHED A WARNING LABEL. ON 12/11/84

9881WARSAWIIN/465801SERIOUS INJURY1 11043-

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M100151~12/19/84~MODULINE~DENTSPLY~F & F KOENIGKRAMERl96 CALDWELL DRIVE~CINCINNATI/OH~45216~MALFUNCTION(M700~ IGENERAL HOSPITAL~FPO~FINAL~DENTSPLY RECEIVED COMPLAINT ALLEGING BACK INJURY DUE TO MOVING A STRETCHER WHEN THE BRAKES LOCKED CAUSING INJURY TO BACK. LAWSUIT BEING CONTESTED. INVESTIGATION BEING CONDUCTED BY DENTSPLY'S INSURANCE CO. DENTSPLY DISCLAIMS ANY RESPONSIBILITY FOR THIS INCIDENT SINCE THIS KIND OF INCIDENT NORMALLY IS PREVENTED OR CORRECTED BY HOSPITAL MAINTENANCE TIGHTENING CASTER BOLTS TO AVOID EXCESSIVE WOBBLE OR PLAY. CO HAS SOLD 1,333 M700 STRETCHERS OVER THE PAST FIVE YEARS AND THIS IS THE ONLY REPORT RECEIVED OF SUDDEN BRAKE LOCKING.~THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M100030/12/19/84~SEVRITON~DENTSPLY~DENTSPLY INTERNATIONAL INCIP.0. BOX 8721YORKIPA1174051SERIOUS INJURY1 I lDENTALlEMAlPRELIMINARYlTRAINEE AT SCHOOL FOR DENTAL ASSISTANTS SPLASHED LIQUID MONOMER IN HER EYE, CONTACTED THE FIRM FOR EMERGENCY ADVICE. WAS TOLD TO FLUSH WITH WATER FOR 45 MINUTES AND CONSULT AN OPHTHAMOLOGIST. DR DIAGNOSED A SLIGHT BURN. GAVE HER OPHTHALMIC CREAM AND INSTRUCTED HER TO AVOID LIGHT. COMPLETE RECOVERY EXPECTED OVERNIGHT. MFG DISCLAIMS ANY RESPONSIBILITY FOR THIS. CAUSED BY USER ERROR. PRODUCT ON THE MARKET 30 YEARS. FIRST SUCH COMPLAINT.~CAUSE KNOWN - OTHER MlOOO90~12/19/84~BECHTOL FEMORAL COMPONENTlRICHMEDIlRICHARDS MEDICAL CO. 11450 BROOKS RDIMEMPHISITN1381161SERIOUS INJURY1 112- 073810RTHOPEDICIKWLIPRELIMINARY~IMPLANT BROKE THROUGH AT THE STEM SECTION. HAD BEEN IMPLANTED FOR 5 1/2 YEARS BEFORE IT BROKE. REPLACEMENT (REVISION) SURGERY DONE IN 1983. NO LONGER BEING MANUFACTURED SINCE FEBRUARY 1981.lCAUSE UNKNOWN M100103 /12/18/841APNEA MONITORlAEQUMEDIlAEQUITRON MEDICAL INC114130 23RD AVE NIPLYMOUTHIMN1554411DEATHl I1ANESTHESIOLOGYIFLSIFINALlFIRM WAS INFORMED 12/14/84 OF DEATH. INFANT WAS BEING MONITORED, ALARM SOUNDED. PARENT RESPONDED, COULD NOT RESUSCITATE INFANT. PARENT RESPONDED TO AN APNEA ALARM ON ABOUT THE 5TH BEEP AND FOUND THE BABY BLUE AND LIFELESS. SHE ADMINSTERED CPR AND THE AMBULANCE ARRIVED WITHIN 3 MINUTES. THE RIDE TO THE HOSPITAL WAS 33 MINUTES WHERE THE BABY WAS RE-STIMULATED. THE INFANT NEVER REGAINED CONSCIOUSNESS, HAD INTERMITTENT SEIZURES, SURVIVED 6-8 HOURS AND DIED AT THE HOSPITAL. THE BABY WAS ON SOME TYPE OF MEDICATION FOR A SEIZURE DISORDER. THE BABY WAS 3-4 MONTHS OF AGE. THE MONITOR WAS SERVICED BY AMBASSADOR ON 10/17/84 AND 11/06/84 AND FOUND TO BE OPERATING NORMALLY. THE INFORMATION OBTAINED TO DATE INDICATES PROPER MONITOR FUNCTION. THE MONITOR IS INTENDED ONLY TO ALERT THE PARENT NOT TO PROVIDE ANY STIMULUS TO THE PATIENT.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. INFORMATION INDICATES THAT THE MEDICAL DEVICE DID NOT MALFUNCTION AND THAT THE INCIDENT WAS NOT ATTRIBUTABLE TO THE DEVICE. M100089~12/18/84~URETEROSCOPE SHEATHlKARLSTORENDOAMMER~KARL STORZllOlll WEST JEFFERSON BLVDICULVER CITYICA1902321SERIOUS INJURY1 ~27023E~GASTROENTEROLOGY-UROLOGY~FGB~PRELIMINARY~DURING A URETEROSCOPY THE SHEATH BROKE INTO TWO PARTS. SURGEON PERFORMED OPEN SURGERY TO REMOVE THE STONE THAT WAS IN THE URETER. FIRM NOT AWARE IF SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE PARTS OF THE SHEATH. NO SPECIFICS AT THIS TIME. EXPECT INSTRUMENT FOR EVALUATIONS AND OTHER INFO THAT CAN BE DETERMINED FROM HOSPITAL STAFF.lTHE CAUSE OF THIS EVENT HAS

&

NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. MlOOO86112/17/841DELTALITE FIBERGLASS CASTING TAPElJOHNJOHNPRODlJOHNSON JOHNSON PRODUCT1501 GEORGE STlNEW BRUNSWICKINJ1089031SERIOUS INJURY1 168021GENERAL AND PLASTIC SURGERYlHXTlPRELIMINARYlINJKJRY DEFINED AS 1ST DEGREE BURN. IN LIEU OF ALLOWING THE CASTING MATERIAL TO STAY IN PLACE, NO CAST WAS APPLIED. FIRM IS NOT AWARE OF MEDICAL OR SURGICAL INTERVENTION BY A HEALTH CARE PROFESSIONAL. FULL REPORT WILL FOLLOW INDICATING THE TYPE OF PHYSICAL CONDITION OF PATIENT. PATIENT RECEIVING CORRECTIVE SPLINTING.lOTHER M100027112/18/841ACS HI-TORQUE FLOPPY GUIDEWIRElADVACARDSYSTlADVANCED CARDIOVASCULAR SYSTEMS11395 CHARLESTON RDIMOUNTAIN VIEWICA1940391MALFUNCTIONl I222191CARDIOVASCULAR~DQX~FINALlA PORTION OF FLOPPY GUIDE WIRE LEFT IN A PT AFTER ANGIOPLASTY PROCEDURE. GUIDE CATHETER WAS MFG'D BY USCI. POST DILATATION DR VIEWED WIRE. DR WAS UNAWARE OF WITHDRAWAL RESISTANCE. PT WAS TAKEN TO SURGERY FOR ARTERIAL GRAFT AND WIRE REMOVAL. PATIENT RECOVERING NICELY. PLEASE NOTE THAT ACS HAS NO ADDITIONAL INFORMATION, AT THIS TIME, TO SUBMIT. WE ARE CURRENTLY AWAITING TEST RESULTS THAT HAVE BEEN DELAYED DUE TO ACTIONS OUTSIDE OUR CONTROL. A FOLLOW-UP REPORT WILL BE SUBMITTED AS MORE INFORMATION BECOMES AVAILABLE TO US. IUSER MlOOl21~12/14/84~ELASTOMER CATHETERICRBARD1C.R. BARD111 SPRING STREET~MURRAY HILL/NJ[ SERIOUS IN JURY^ I IGASTROENTEROLOGY- UROLOGY~KOD\PRELIMINARY/FOLEY CATHETER WOULD NOT DEFLATE. UROLOGIST

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X*X*****X**X********x*******x**x*************************RMATION AVAILABLE. FIRM IS NOT SURE IF SERIOUS INJURY OCCURRED. ALSO THIS COULD BE PROCEDURAL ERROR AND NOT A MALFUNCTION. THEY WILL DETERMINE AND REPORT APPROPRIATELY. MFG DISCLAIMER SUBMITTED.lCAUSE UNKNOWN MlOO021~12/17/84~OMNI CALMON, TYPE 21PRECCOSMIPRECISION COSMET111140 BREN ROAD WIMINNETONKA(MN155343lMALFUNCTIONI I lOPHTHALMIClHQLlFINALlADVERSE REACTION IOL. RECEIVED 12/17/84. DIAGNOSIS UNDER SLITLAMP. NOT STABLE. REPLACED UNDER SURGERY. NOT UNUSUAL. NO COMPLICATIONS. LENS WAS REMOVED AND REPLACED BECAUSE DR FELT THE LENS SIZE WAS INCORRECT. PT SEEN ON 12/17 AND DR INDICATED PROGNOSIS GOOD. ICAUSE UNKNOWN MlOOlll~l2/18/84~HARRIS GALANTElZIMMERlZIMMERlPO BOX 7081WARSAWIIN1465801SERIOUS INJURYIACETABULAR COMPONENT[ ~ORTHOPEDIC~KWL~PRELIMINARY~FEMORAL COMPONENT DISLOCATED FROM ACETABULAR COMPONENT. ACETABULAR LINER AND FEMORAL HEAD WERE DAMAGED BY HEALTH CARE PROFESSIONALS DURING ATTEMPTED CLOSED REDUCTION, WHICH REQUIRED SURGICAL INTERVENTION TO CORRECT. LABELING DOES ADVISE RE: DISLOCATION.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY PHYSIOLICAL OR PROCEDURAL FACTORS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. R100091112/14/84 ITRANS WORLD X-RAY CONTROL(TRANWORLXRAY1TRANS WORLD X-RAY C0110210 PINEVILLE ROADlCHARLOTTElNCl IMALFUNCTIONIA150201 lRADIOLOGICALlKPRlPRELIMINARY~ACCID ENTAL RADIATION OCCURRENCE. SERVICE ENGINEER MADE SERVICE CALL AND FOUND ON OCCASION MISFIRING OF SCR (ELECTRONIC CONTACTORS) CAUSING PRE-EMISSION WHEN WARMING UP FUSE DURING PREP CYCLE. THE BRIEF EMISSION LASTS ABOUT 1/120 SEC. THEN CONTROL INITIATES NORMAL EXPOSURE ACCORDING TO PRESET TIME. DR REQUESTED SERVICE VISIT BECAUSE HE WAS SEEING PROBLEM WITH OVER EXPOSURE ON FILMS. ICAUSE KNOWN - OTHER M100112 112/18/8414 PRONG CYCLER SET W/CONNECTOR TUBEITRAVLABOITRAVENOL LAB INCll BAXTER PKWY~DEERFIELD~IL~60015~MALFUNCTION~5C 442115C 4421~GASTROENTEROLOGY-UROLOGY~KPF~PRELIMINARY~LEAKS IN SOLUTION LINE PUMP SEGMENT. PATIENT CONTRACTED STAPH EPI PERITONITIS, POSSIBLY ASSOCIATED WITH INCREASED DISCONNECTS WHEN CHANGING TUBINGS.lCAUSE KNOWN - OTHER MlO0084112/18/841FORETREND 100 ANESTHESIA MACHINEIPURIBENNIPURITAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKlKS1662251SERIOUS INJURY1 1 lANESTHESIOLOGYlBSZlPRELIMINARYlPT BECAME DISCONNECTED FROM ANESTHESIA MACHINE AND ENDOTRACHEAL TUBE. DR RPTD SERIOUS INJURY WHICH MAY RESULT IN DEATH. ONE PATIENT INVOLVED WAS A CHILD. DR STATED THE F-100 MACHINE DID NOT MALFUNCTION. A PURITAN BENNETT SERVICE MAN CHECKED MACHINE AND FOUND MACHINE TO MEET SPECIFICATIONS.1CAUSE UNKNOWN M100085~12/18/84~M-3OOOXA~PURIBENN~PURITAN BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 25905lOVERLAND PARKIKS1662251DEATHI I lANESTHESIOLOGYlCQKlFINALlHOME CARE PATIENT BECAME DISCONNECTED AT TRACHEAL TUBE AND DIED. VENTILATOR ALARM SOUNDED AND WAS HEARD BY A DAUGHTER IN AN UPSTAIRS BEDROOM. DAUGHTER DISCOVERED THE DISCONNECT AND TRIED TO RECONNECT THE TUBE BUT NO RESPONSE. PARAMEDICS TRANSPORTED PT TO HOSPITAL. VENTILATOR CHECKED BY CO AND HAS BEEN FOUND TO MEET SPECIFICATIONS. DISTRIBUTOR STATED THAT VENTILATOR SEEMED TO OPERATE PROPERLY IN ALL RESPECTS. ELBOW AND ADAPTER WHERE THE DISCONNECT

WAS REPORTED TO OCCUR ARE NOT MANUFACTURED OR DISTRIBUTED BY PURITAN BENNETT. MFG DISCLAIMER SUBMITTED.lTHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS'NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE. MlOOO88112/18/841BLITT CENTRAL CATHETER TRAYIARGOMEDIIARGON MEDICAL CORPlPO BOX 19701ATHENSITX175751lDEATHl I497615/CARDIOVASCULAR~DQOlFINAL~THERE WERE SOME COMPLICATIONS WITH SOME PATIENTS INCLUDING "DEATHS". HOSP CONDUCTING INVESTIGATION. ONE DEATH. TWO PATIENTS WITH COMPLICATIONS. HOWEVER, NO CONNECTION HAS BEEN MADE BY THE HOSPITAL BETWEEN PRODUCT AND PT COMPLICATIONS. NO PRODUCT COMPONENT HAS BEEN INDICATED, NOR HAS ANY PRODUCT BEEN RETURNED BY THE HOSP. MFG DISCLAIMER SUBMITTED.lCAUSE UNKNOWN M100082 112/17/84 \CARDIAC PULSE GENERATORlCOOKPACElCOOK PACEMAKER CORPIP.0. BOX 5291LEECHBURGIPA115656lSERIOUS INJURY1325TI lCARDIOVASCULARlDXYlPRELIMINARY~UNIT EXPLANTED. NOTIFIED BY CORDIS CORP. (DR. SENT TO CORDIS). IMPLANTED APPROXIMATELY ONE YEAR. EXPLANTED IN CALIF. ELECTIVE REMOVAL BECAUSE OF THROMBOSIS ON LEFT SHOULDER. PACEMAKER SENT TO CORDIS AND SENT SIX MONTHS LATER TO COOK. PATIENT CONDITION SATISFACTORY.lCAUSE UNKNOWN M100025~12/18/84~BAK-ON~JENEINDU~JENERIC INDUSTRIES INC1125 N PLAINS INDUSTRIAL RD, PO BOX 7241WELLINGTONICT106492lMALFUNCTIONI I lDENTALlELZlPRELIMINARYlMETAL CROWN MATERIAL - ALLERGIC REACTION. NEVER BEEN REPORTED BEFORE.~THIS REPORT HAS BEEN REVIEWED AND IT HAS BEEN DETERMINED THAT THE PRODUCT IS NOT REGULATED BY CDRH. IT HAS BEEN FORWARDED TO THE APPROPRIATE FDA CENTER OR FEDERAL AGENCY FOR FOLLOW-UP. MlOOO98(12/19/841PROLENE POLYPROPYLENE SUTURE SIZE OlETHICONlETHICON INCIROUTE 221SOMMERVILLEINJ108876lSERIOUS INJURY1 18424HlGENERAL AND PLASTIC SURGERY~GAW~PRELIMINARY~WOUND DEHISCENCE 24 HRS POST-OP A LAPAROTOMY PROCEDURE. REQUIRED RECLOSING OF WOUND. NO ADDITIONAL INFORMATION AVA1LABLE.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE CAUSE ASSOCIATED WITH THIS TYPE OF EVENT IS USUALLY ATTRIBUTED TO THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FURTHER FOLLOW-UP AND/OR ACTION IS INDICATED. MlO0087112/18/84lSWAN-GANZ THERMODILUTION CATHETERIAMEREDWALABOIAMERICAN EDWARDS LABS117221 RED HILL AVEIIRVINEICA1927141SERIOUS INJURY193A-131- 7 ~ 1 ~CARDIOVASCULAR~DYG~FINAL~CARDIAC CATHETER KNOTTED AFTER INSERTION. AS CATHETER WAS BEING REMOVED FROM THE VEIN, THE CATHETER BROKE. VEIN WAS OPENED AND FRAGMENT WAS EASILY RETRIEVED. CO HAS NOT VERIFIED ADDITIONAL DETAILS. PRODUCT TO BE RETURNED TO CO.lTHE CAUSE OF THIS PROBLEM HAS NOT BEEN DETERMINED. THIS IS A RECOGNIZED ADVERSE AFFECT ASSOCIATED WITH THE DEVICE OR ITS USE AS STATED IN LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. BOTH THE FREQUENCY AND THE SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. MlOOO26112/18/84lSINGLE PT DIALYSIS MACHINEIDRAKWILLIDRAKE WILLOCK113520 SE PHEASANT CT~PORTLAND~OR/97222~MALFUNCTION~4215~ IGASTROENTEROLOGY- UROLOGY~FKP~PRELIMINARY~SERVICE REP VISITED PT AT HOME. SYSTEM DEVELOPED HIGH POSITIVE BACK PRESSURE. PT HELPER SHUT OFF MACHINE, DISCONNECTED PT. SERVICE REP FOUND MALFUNCTIONING CHECK VALVE. VALVE PLUGGED - CHANGED

VALVE. AT DIALYSIS CENTER PT RECEIVED TWO UNITS OF BLOOD. PT STABLE.IMFG/MATERIALS MlOOlO2~l2/l8/841NEONATAL PT MONITORIHEWLPACKIHEWLETT PACKARD1175 WYMAN ST, WALTHAM DIVISIONlWALTHAMlMA~O2254~SERIOUS INJURY178801A, 78833~1 ~CARDIOVASCULAR~DRT~FINAL~INJURY TO INFANT REPORTED TO BE BURNS AT SITE OF APPLICATION OF DISPOSABLE ELECTRODES. INFANT MONITORED AT BEDSIDE BY MDL #78801A NEONATAL MONITOR. INFANT WAS MOVED TO ANOTHER ROOM AND MONITORED BY MDL #78833A. AT THIS TIME INJURY WAS NOTED. OTHER EQUIPMENT CONNECTED TO PT WHEN INJURY WAS NOTED: AIR SHIELDS C-100 INCUBATOR, IMED MDL 976 INFUSION PUMP. BURNS AT THE SITE OF 3M CO DISPOSABLE ELECTRODE. HEWLETT PACKARD WILL CONDUCT INVESTIGATION. COMPANY USED DISCLAIMER LANGUAGE IN UPDATED TEXT.lCAUSE UNKNOWN M100071)12/18/84 IPLAYTEX TAMPON1 INTLPLAYI INTERNATIONAL PLAYTEX1215 COLLEGE ROADIPARAMUSINJ107652lSERIOUS INJURY1 I /OB/GYNIHILIPRELIMINARYlREPORTER STATED HE COULDN'T RELEASE NAME

M100104 112/17/841ARGYLE TEFLON COATED FOLEY CATHETERISHERMEDIISHERWOOD MEDICAL11831 OLIVE STlST LOUIS1M01631031MALFUNCTION~ I IGASTROENTEROLOGY- UROLOGY~KODIPRELIMINARY~LATEX BALLOON ON FOLEY CATHETER BROKE WHILE INSERTED IN PT BLADDER. PT GIVEN A CYSTOSCOPIC EXAM TO DETERMINE IF BALLOON FRAGMENTS REMAINED IN BLADDER. NO FURTHER INFORMATION AT THIS TIME. HOSP REFUSED TO PROVIDE FURTHER INFORMATION EXCEPT UPON WRITTEN

OF ATTORNEY WITHOUT FURTHER AUTHORIZATION FROM HIS FIRM.~OTHER

REQUEST. FIRM HAS REQUESTED INFORMATION IN WRITING.~THIS REPORT HAS BEEN EVALUATED BY THE PRODUCT REVIEW GROUP, AND THEY HAVE DETERMINED THAT NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND THE SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. MlO0099112/20/841BARD SILICONE COATED CATHETERICRBARDICR BARD, INCllll SPRING STIMURRAY HILLINJ1079741SERIOUS INJURY11267161 IGASTROENTEROLOGY-

STYLET TO PUNCTURE THE BALLOON. PATIENT HAD NO PROBLEMS AS A RESULT OF THIS. PATIENT WAS RECATHETERIZED AND IS DOING FINE. INFORMATION SUBMITTED TO SALES REPRESENTATIVE.lOTHER Ml00116~12/20/84~AMERICAN HEYER SCHULTEIMENTORIMENTOR CORP1600 PINE AVENUEIGOLETAICA/93117~MALFUNCTION~LJA~UA~GENERAL AND PLASTIC

UROLOGY~KOD~PRELIMINARY~BALLOON WOULD NOT DEFLATE. UROLOGIST HAD TO USE A

SURGERY~FTR~FINAL~SHELL OF PROSTHESIS RUPTURED, RESULTING IN GEL LEAKING OUT INTO THE SURROUNDING TISSUE. PT UNAWARE WHEN RUPTURE OCCURRED. PT FELT DISCOMFORT ABOUT TWO MONTHS AGO. SURGERY PERFORMED AND PROSTHESIS AND GEL REMOVED. PROSTHESIS WAS IMPLANTED 8 YEARS AGO AND COMPANY WAS OWNED BY OTHER MFG, SO LABELING, AT THIS TIME, IS UNKNOWN.ICAUSE UNKNOWN M100053~12/20/84~COMBINATION ECONOMY SYRINGEICRBARDICR BARD/HOME HEALTH DIVI731 CENTRAL AVEIMURRAY HILLINJ1079741SERIOUS INJURY~12~12~GASTROENTEROLOGY-UROLOGY~FCE~PRELIMINARY~NONSTERILE DEVICE MADE LONG BEFORE PREAMENDMENTS. USE OF BAG MADE STOMACH HURT AND LEFT REDDISH BURN MARK FROM RECTUM TO LEFT KNEE. DOCTOR IDENTIFIED BURN(S) IN BOWEL AREA. A RED DYE IS EMITTED FROM THE BAG WHEN IN USE.lCAUSE UNKNOWN MlOOO96112/17/841BJORK SHILEY CONVEXO-CONCAVE SIZE 231SHILEYISHILEY INC.117600 GILETTE AVEIIRVINEICA1927141SERIOUS INJURY~XABC~ ~CARDIOVASCULAR~LWQ~FINAL~OUTLET STRUT FRACTURE. NO ADDITIONAL INFORMATION AVAILABLE. MFG DISCLAIMER SUBMITTED. IT APPEARS THAT THE MAIN CAUSE OF VALVE FAILURE WAS FATIGUE. NO METALLURGICAL OR MANUFACTURING DEFECTS RESPONSIBLE FOR THE FRACTURE COULD BE IDENTIFIED.IMFG/PROCEDURE

M100151~12/19/84jMODULINE~DENTSPLY~F & F KOENIGKRAMER196 CALDWELL DRIVE~CINCINNATI~OH~45216~MALFUNCTION~M7OO~~GENERAL HOSPITALlFPOlFINALIDENTSPLY RECEIVED COMPLAINT ALLEGING BACK INJURY DUE TO MOVING A STRETCHER WHEN THE BRAKES LOCKED CAUSING INJURY TO BACK. LAWSUIT BEING CONTESTED. INVESTIGATION BEING CONDUCTED BY DENTSPLY'S INSURANCE CO. DENTSPLY DISCLAIMS ANY RESPONSIBILITY FOR THIS INCIDENT SINCE THIS KIND OF INCIDENT NORMALLY IS PREVENTED OR CORRECTED BY HOSPITAL MAINTENANCE TIGHTENING CASTER BOLTS TO AVOID EXCESSIVE WOBBLE OR PLAY. CO HAS SOLD 1,333 M700 STRETCHERS OVER THE PAST FIVE YEARS AND THIS IS THE ONLY REPORT RECEIVED OF SUDDEN BRAKE LOCKING.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF

AND/OR OTHER ACTION IS INDICATED. M100030)12/19/84~SEVRITON~DENTSPLY~DENTSPLY INTERNATIONAL INCIP.0. BOX 8721YORKIPAI174051SERIOUS INJURYIIIDENTALIEMAIPRELIMINARYITRAINEE AT SCHOOL FOR DENTAL ASSISTANTS SPLASHED LIQUID MONOMER IN HER EYE, CONTACTED THE FIRM FOR EMERGENCY ADVICE. WAS TOLD TO FLUSH WITH WATER FOR 45 MINUTES AND CONSULT AN OPHTHAMOLOGIST. DR DIAGNOSED A SLIGHT BURN. GAVE HER OPHTHALMIC CREAM AND INSTRUCTED HER TO AVOID LIGHT. COMPLETE RECOVERY EXPECTED OVERNIGHT. MFG DISCLAIMS ANY RESPONSIBILITY FOR THIS. CAUSED BY USER ERROR. PRODUCT ON

M100090~12/19/84~BECHTOL FEMORAL COMPONENTlRICHMEDIlRICHARDS MEDICAL CO.11450

073810RTHOPEDICIKWLIPRELIMINARYIIMPLANT BROKE THROUGH AT THE STEM SECTION. HAD BEEN IMPLANTED FOR 5 1/2 YEARS BEFORE IT BROKE. REPLACEMENT (REVISION) SURGERY DONE IN 1983. NO LONGER BEING MANUFACTURED SINCE FEBRUARY 198l.lCAUSE UNKNOWN M 1 O0 103 I 12/18/84JAPNEA MONITORlAEQUMEDIlAEQUITRON MEDICAL INCll4 130 23RD AVE NIPLYMOUTHIMNI554411DEATH/IlANESTHESIOLOGYlFLSlFINALlFIRM WAS INFORMED 12/14/84 OF DEATH. INFANT WAS BEING MONITORED, ALARM SOUNDED. PARENT RESPONDED, COULD NOT RESUSCITATE INFANT. PARENT RESPONDED TO AN APNEA ALARM ON ABOUT THE 5TH BEEP AND FOUND THE BABY BLUE AND LIFELESS. SHE ADMINSTERED CPR AND THE AMBULANCE ARRIVED WITHIN 3 MINUTES. THE RIDE TO THE HOSPITAL WAS 33 MINUTES WHERE THE BABY WAS RE-STIMULATED. THE INFANT NEVER REGAINED CONSCIOUSNESS, HAD INTERMITTENT SEIZURES, SURVIVED 6-8 HOURS AND DIED AT THE HOSPITAL. THE BABY WAS ON SOME TYPE OF MEDICATION FOR A SEIZURE DISORDER. THE

THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP

THE MARKET 30 YEARS. FIRST SUCH COMPLAINT.ICAUSE KNOWN - OTHER

BROOKS RDIMEMPHISITN1381161SERIOUS INJURY1112-

BABY WAS 3-4 MONTHS OF AGE. THE MONITOR WAS SERVICED BY AMBASSADOR ON 10117184 AND 11/06/84 AND FOUND TO BE OPERATING NORMALLY. THE INFORMATION OBTAINED TO DATE INDICATES PROPER MONITOR FUNCTION. THE MONITOR IS INTENDED ONLY TO ALERT THE PARENT NOT TO PROVIDE ANY STIMULUS TO THE PATIENT.)THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. INFORMATION INDICATES THAT THE MEDICAL DEVICE DID NOT MALFUNCTION AND THAT THE INCIDENT WAS NOT ATTRIBUTABLE TO THE DEVICE. M 1000891 1211 8/841URETEROSCOPE SHEATHIKARLSTORENDOAMERIKARL STORZI 1 O 1 1 1 WEST JEFFERSON BLVDICULVER CITYICA1902321SERIOUS INJURYl127023E1GASTROENTEROLOGY- UROLOGYIFGBIPRELIMINARYIDURING A URETEROSCOPY THE SHEATH BROKE INTO TWO PARTS. SURGEON PERFORMED OPEN SURGERY TO REMOVE THE STONE THAT WAS IN THE URETER. FIRM NOT AWARE IF SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE PARTS OF THE SHEATH. NO SPECIFICS AT THIS TIME. EXPECT INSTRUMENT FOR EVALUATIONS AND OTHER INFO THAT CAN BE DETERMINED FROM HOSPITAL STAFF.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE

PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M 1000861 12/17/841DELTALITE FIBERGLASS CASTING TAPEIJOHNJOHNPRODIJOHNSON & JOHNSON PRODUCT1501 GEORGE STlNEW BRUNSWICK/NJ108903/SERIOUS INJURYl(68021GENERAL AND PLASTIC SURGERYIHXTIPRELIMINARYIINJURY DEFINED AS 1ST DEGREE BURN. IN LIEU OF ALLOWING THE CASTING MATERIAL TO STAY IN PLACE, NO CAST WAS APPLIED. FIRM IS NOT AWARE OF MEDICAL OR SURGICAL INTERVENTION BY A HEALTH CARE PROFESSIONAL. FULL REPORT WILL FOLLOW INDICATING THE TYPE OF PHYSICAL CONDITION OF PATIENT. PATIENT RECEIVING CORRECTIVE SPLINTING.IOTHER M100027112/18/841ACS HI-TORQUE FLOPPY GUIDEWIREIADVACARDSYSTIADVANCED CARDIOVASCULAR SYSTEMS1 1395 CHARLESTON RDIMOUNTAIN VIEW~CA/94039~MALFUNCTION~~22219~CARDIOVASCULAR~DQX~FINAL~A PORTION OF FLOPPY GUIDE WIRE LEFT IN A PT AFTER ANGIOPLASTY PROCEDURE. GUIDE CATHETER WAS MFGD BY USCI. POST DILATATION DR VIEWED WIRE. DR WAS UNAWARE OF WITHDRAWAL RESISTANCE. PT WAS TAKEN TO SURGERY FOR ARTERIAL GRAFT AND WIRE REMOVAL. PATIENT RECOVERING NICELY. PLEASE NOTE THAT ACS HAS NO ADDITIONAL INFORMATION, AT THIS TIME, TO SUBMIT. WE ARE CURRENTLY AWAITING TEST RESULTS

REPORT WILL BE SUBMITTED AS MORE INFORMATION BECOMES AVAILABLE TO US.IUSER MlO0121/12/14/84~ELASTOMER CATHETERICRBARD1C.R. BARD111 SPRING STREETIMURRAY

CATHETER WOULD NOT DEFLATE. UROLOGIST RECEIVED CATHETER WITH BALLOON INFLATED. PATIENT IS OK./MFG/PROCEDURE V100101/12/14/84~CHEM STRIP BGlBOEHMANNlBOEHRINGER MANNHEIM DIAG1915 HAGUE ROAD/INDIANAPOLISIIN146250~SERIOUS INJURYlI5031CLINICAL CHEMISTRYICFRIPRELIMINARYIFIRM RECEIVED LETTER 12/10/84. ADVERSE REACTION TO LOT #212052. REASON FOR REPORTING ADVERSE REACTION MEDICAL INTERVENTION. (NO SERIOUS INJURY)./ M100097~12/17/84~SHILEY MEMBRANE OXYGENATORlSHILEYISHILEY, INCil7600 GILETTE AVE~IRVINE(CA~92714~MALFUNCTION~M-200O~~ANESTHESIOLOGY~CAN~FINAL~GAS IN ARTERIAL LINE FLOWED INTO PATIENT. NO OTHER INFORMATION AVAILABLE. FIRM IS NOT SURE IF SERIOUS INJURY OCCURRED. ALSO THIS COULD BE PROCEDURAL ERROR AND NOT A MALFUNCTION. THEY WILL DETERMINE AND REPORT APPROPRIATELY. MFG DISCLAIMER SUBMITTED.ICAUSE UNKNOWN M100021~12/17/84~OMNI CALMON, TYPE 2/PRECCOSMIPRECISION COSMETllll40 BREN ROAD WIMINNETONKAIMN155343lMALF~CTIONIJIOPHTHALMICIHQL(FINALlADVERSE REACTION IOL. RECEIVED 12/17/84. DIAGNOSIS UNDER SLITLAMP. NOT STABLE. REPLACED UNDER SURGERY. NOT UNUSUAL. NO COMPLICATIONS. LENS WAS REMOVED AND REPLACED BECAUSE DR FELT THE LENS SIZE WAS INCORRECT. PT SEEN ON 12/17 AND DR INDICATED PROGNOSIS GOOD.ICAUSE UNKNOWN M10011 I j12/18/841HARRIS GALANTEIZIMMER/ZIMMERJPO BOX 7081WARSAWIIN1465801SERIOUS INJURYIACETABULAR COMPONENT~/ORTHOPEDIC~KWL/PRELIMINARY~FEMORAL COMPONENT DISLOCATED FROM ACETABULAR COMPONENT. ACETABULAR LINER AND FEMORAL HEAD WERE DAMAGED BY HEALTH CARE PROFESSIONALS DURING ATTEMPTED CLOSED REDUCTION, WHICH REQUIRED SURGICAL INTERVENTION TO CORRECT. LABELING DOES ADVISE RE: DISLOCATION.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED.

THE EVENT MAY HAVE BEEN CAUSED BY PHYSIOLICAL OR PROCEDURAL FACTORS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

THAT HAVE BEEN DELAYED DUE TO ACTIONS OUTSIDE OUR CONTROL. A FOLLOW-UP

HILLlNJllSERIOUS INJURY/~~GASTROENTEROLOGY-UROLOGYII(OD/PARY~FOLEY

HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT

R100091112/14/841TRANS WORLD X-RAY CONTROLITRANWORLXRAYITRANS WORLD X-RAY COI 102 1 O PINEVILLE ROAD~CHARLOTTE~NC~~MALFUNCTION~Al5020~~RADIOLOGICAL~IR~PRELIMINARY~ACCIDENT AL RADIATION OCCURRENCE. SERVICE ENGINEER MADE SERVICE CALL AND FOUND ON

OCCASION MISFIRING OF SCR (ELECTRONIC CONTACTORS) CAUSING PRE-EMISSION WHEN WARMING UP FUSE DURING PREP CYCLE. THE BRIEF EMISSION LASTS ABOUT 11120 SEC. THEN CONTROL INITIATES NORMAL EXPOSURE ACCORDING TO PRESET TIME. DR REQUESTED SERVICE VISIT BECAUSE HE WAS SEEING PROBLEM WITH OVER EXPOSURE ON

MlOO112112/18/8414 PRONG CYCLER SET W/CONNECTOR TUBEITRAVLABOITRAVENOL LAB INCll BAXTER PKWY~DEERFIELD/IL~60015~MALFUNCTION~5C 4421j5C

SEGMENT. PATIENT CONTRACTED STAPH EPI PERITONITIS, POSSIBLY ASSOCIATED WITH

FILMS.ICAUSE KNOWN - OTHER

442 1 IGASTROENTEROLOGY-UROLOGYII(PF/PRELIMINARY/LEAKS IN SOLUTION LINE PUMP

INCREASED DISCONNECTS WHEN CHANGING TUBINGS./CAUSE KNOWN - OTHER M 1000841 1211 81841FORETREND 1 O0 ANESTHESIA MACHINEIPURIBENNIPURITAN-BENNETT COW19401 INDIAN CREEK PKWY, PO BOX 2590510VERLAND PARKIKS1662251SERIOUS INJURYlllANESTHESIOLOGYJBSZ/PRELIMINARYIPT BECAME DISCONNECTED FROM ANESTHESIA MACHINE AND ENDOTRACHEAL TUBE. DR W T D SERIOUS INJURY WHICH MAY

DID NOT MALFUNCTION. A PURITAN BENNETT SERVICE MAN CHECKED MACHINE AND FOUND MACHINE TO MEET SPECIFICATIONS.1CAUSE UNKNOWN

PO BOX 25905lOVERLAND PARKIKS~662251DEATH~~ANESTHESIOLOGY/CBAL~HOME CARE PATIENT BECAME DISCONNECTED AT TRACHEAL TUBE AND DIED. VENTILATOR ALARM SOUNDED AND WAS HEARD BY A DAUGHTER IN AN UPSTAIRS BEDROOM. DAUGHTER DISCOVERED THE DISCONNECT AND TRIED TO RECONNECT THE TUBE BUT NO RESPONSE. PARAMEDICS TRANSPORTED PT TO HOSPITAL. VENTILATOR CHECKED BY CO AND HAS BEEN FOUND TO MEET SPECIFICATIONS. DISTRIBUTOR STATED THAT VENTILATOR SEEMED TO OPERATE PROPERLY IN ALL RESPECTS. ELBOW AND ADAPTER WHERE THE DISCONNECT WAS REPORTED TO OCCUR ARE NOT MANUFACTURED OR DISTRIBUTED BY PURITAN BENNETT. MFG DISCLAIMER SUBMITTED.ITHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE. M100088112/18/841BLITT CENTRAL CATHETER TRAYIARGOMEDIIARGON MEDICAL COWlPO BOX 1970lATHENSITX17575 1 IDEATHI49761 5(CARDIOVASCULARIDQOlFINALlTHERE WERE SOME COMPLICATIONS WITH SOME PATIENTS INCLUDING "DEATHS". HOSP CONDUCTING INVESTIGATION. ONE DEATH. TWO PATIENTS WITH COMPLICATIONS. HOWEVER, NO CONNECTION HAS BEEN MADE BY THE HOSPITAL BETWEEN PRODUCT AND PT COMPLICATIONS. NO PRODUCT COMPONENT HAS BEEN INDICATED, NOR HAS ANY PRODUCT BEEN RETURNED BY THE HOSP. MFG DISCLAIMER SUBMITTED.ICAUSE UNKNOWN M100082(12/17/84~CARDIAC PULSE GENERATORlCOOKPACElCOOK PACEMAKER CORpIP.0. BOX 5291LEECHBURGIPA1156561SERIOUS INJURY1325TIlCARDIOVASCULARlDXYlPRELIMINARY~UNIT EXPLANTED. NOTIFIED BY CORDIS COW. (DR. SENT TO CORDIS). IMPLANTED APPROXIMATELY ONE YEAR. EXPLANTED IN CALIF. ELECTIVE REMOVAL BECAUSE OF THROMBOSIS ON LEFT SHOULDER. PACEMAKER SENT TO CORDIS AND SENT SIX MONTHS LATER TO COOK. PATIENT CONDITION SATISFACTORY./CAUSE UNKNOWN

PO BOX 7241WELLINGTONICT106492~MALFUNCTION~llDENTALlELZlPRELIMINARYlMETAL

HAS BEEN REVIEWED AND IT HAS BEEN DETERMINED THAT THE PRODUCT IS NOT REGULATED BY CDRH. IT HAS BEEN FORWARDED TO THE APPROPRIATE FDA CENTER OR

RESULT IN DEATH. ONE PATIENT INVOLVED WAS A CHILD. DR STATED THE F- 1 O0 MACHINE

M100085~12/18/84~M-3000XA~PURIBENN/PURITAN BENNETT CORP19401 INDIAN CREEK PKWY,

M 100025 11211 8/841BAK-ONIJENEINDUIJENERIC INDUSTRIES INCll25 N PLAINS INDUSTRIAL RD,

CROWN MATERIAL - ALLERGIC REACTION. NEVER BEEN REPORTED BEFOREITHIS REPORT

FEDERAL AGENCY FOR FOLLOW-UP. M 1000981 12/19/84/PROLENE POLYPROPYLENE SUTURE SIZE OlETHICONlETHICON INCIROUTE 221SOMMERVILLEINJ1088761SERIOUS INJURYII8424H/GENERAL AND PLASTIC

PROCEDURE. REQUIRED RECLOSING OF WOUND. NO ADDITIONAL INFORMATION AVAILABLE.ITHE CAUSE OF THIS EVENT H A S NOT BEEN DETERMINED. HOWEVER, THE

SURGERYIGAWIPRELIMINARYIWOUND DEHISCENCE 24 HRS POST-OP A LAPAROTOMY

CAUSE ASSOCIATED WITH THIS TYPE OF EVENT IS USUALLY ATTRIBUTED TO THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE

IS INDICATED. M1000871 124 8/841SWAN-GANZ THERMODILUTION CATHETERIAMEREDWALABOIAMERICAN

7FIICARDIOVASCULARIDYGIFINALICARDIAC CATHETER KNOTTED AFTER INSERTION. AS CATHETER WAS BEING REMOVED FROM THE VEIN, THE CATHETER BROKE. VEIN WAS OPENED AND FRAGMENT WAS EASILY RETRIEVED. CO HAS NOT VERIFIED ADDITIONAL DETAILS. PRODUCT TO BE RETURNED TO CO.ITHE CAUSE OF THIS PROBLEM HAS NOT BEEN DETERMINED. THIS IS A RECOGNIZED ADVERSE AFFECT ASSOCIATED WITH THE DEVICE OR ITS USE AS STATED IN LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. BOTH THE FREQUENCY AND THE SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M10002611211 81841SINGLE PT DIALYSIS MACHINEIDRAKWILLIDRAKE WILLOCKi13520 SE

UROLOGY/FKPIPRELIMINARYISERVICE REP VISITED PT AT HOME. SYSTEM DEVELOPED HIGH POSITIVE BACK PRESSURE. PT HELPER SHUT OFF MACHINE, DISCONNECTED PT. SERVICE REP FOUND MALFUNCTIONING CHECK VALVE. VALVE PLUGGED - CHANGED VALVE. AT DIALYSIS CENTER PT RECEIVED TWO UNITS OF BLOOD. PT STABLE.IMFG/MATERIALS M100102~12/18/84~NEONATAL PT MONITORIHEWLPACKIHEWLETT PACKARD1175 WYMAN ST, WALTHAM DIVISIONIWALTHAMIMA1022541SERIOUS INJURY178801A, 78833A1ICARDIOVASCULARIDRTJFINALIINJURY TO INFANT REPORTED TO BE BURNS AT SITE OF APPLICATION OF DISPOSABLE ELECTRODES. INFANT MONITORED AT BEDSIDE BY MDL #78801A NEONATAL MONITOR. INFANT WAS MOVED TO ANOTHER ROOM AND MONITORED BY MDL #78833A. AT THIS TIME INJURY WAS NOTED. OTHER EQUIPMENT CONNECTED TO PT WHEN INJURY WAS NOTED: AIR SHIELDS C-100 INCUBATOR, IMED MDL 976 INFUSION PUMP. BURNS AT THE SITE OF 3M CO DISPOSABLE ELECTRODE. HEWLETT PACKARD WILL CONDUCT INVESTIGATION. COMPANY USED DISCLAIMER LANGUAGE IN UPDATED TEXT.ICAUSE UNKNOWN M10007 1 11211 8/841PLAYTEX TAMPONIINTLPLAYIINTERNATIONAL PLAYTEX12 15 COLLEGE ROAD/PARAMUSINJ1076521SERIOUS INJURY(JIOB/GYNIHILIPRELIMINARYIREPORTER STATED HE COULDN'T RELEASE NAME OF ATTORNEY WITHOUT FURTHER AUTHORIZATION FROM HIS FIRM.IOTHER M100104112/17/841ARGYLE TEFLON COATED FOLEY CATHETER/SHERMEDIISHERWOOD MEDICAL1 183 1 OLIVE STIST LOUISIM0163 103/MALFUNCTION~~~GASTROENTEROLOGY- UROLOGYIKODIPRELIMINARYILATEX BALLOON ON FOLEY CATHETER BROKE WHILE INSERTED IN PT BLADDER. PT GIVEN A CYSTOSCOPIC EXAM TO DETERMINE IF BALLOON FRAGMENTS REMAINED IN BLADDER. NO FURTHER INFORMATION AT THIS TIME. HOSP REFUSED TO PROVIDE FURTHER INFORMATION EXCEPT UPON WRITTEN REQUEST. FIRM HAS REQUESTED INFORMATION IN WRITING.ITHIS REPORT HAS BEEN EVALUATED BY THE PRODUCT REVIEW GROUP, AND THEY HAVE DETERMINED THAT NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND THE SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M100099112/20/841BARD SILICONE COATED CATHETERICRBARDICR BARD, INCll 1 1 SPRING STlMURRAY HILLINJ107974/SERIOUS INJURY1 1267 1611GASTROENTEROLOGY- UROLOGYIKODIPRELIMINARYIBALLOON WOULD NOT DEFLATE. UROLOGIST HAD TO USE A STYLET TO PUNCTURE THE BALLOON. PATIENT HAD NO PROBLEMS AS A RESULT OF THIS. PATIENT WAS RECATHETERIZED AND IS DOING FINE. INFORMATION SUBMITTED TO SALES REPRESENTATIVE.IOTHER M1001 161121201841AMERICAN HEYER SCHULTEIMENTORIMENTOR CORP/600 PINE AVENUEIGOLETAICA193 1171MALFUNCTIONIUAIUA/GENERAL AND PLASTIC SURGERYlFTRlFINALlSHELL OF PROSTHESIS RUPTURED, RESULTING IN GEL LEAKING OUT

PERIODICALLY MONITORED TO DETERMINE IF ANY FURTHER FOLLOW-UP AND/OR ACTION

EDWARDS LABS117221 RED HILL AVEIIRVINEICA1927141SERIOUS INJURYJ93A-131-

PHEASANT CT~PORTLAND/OR~97222~MALFUNCTION~4215~~GASTROENTEROLOGY-

INTO THE SURROUNDING TISSUE. PT UNAWARE WHEN RUPTURE OCCURRED. PT FELT DISCOMFORT ABOUT TWO MONTHS AGO. SURGERY PERFORMED AND PROSTHESIS AND GEL REMOVED. PROSTHESIS WAS IMPLANTED 8 YEARS AGO AND COMPANY WAS OWNED BY OTHER MFG, SO LABELING, AT THIS TIME, IS UNKNOWN.ICAUSE UNKNOWN M1 000531 12/20/841COMBINATION ECONOMY SYRINGEICRBARDICR BARD/HOME HEALTH

UROLOGYIFCElPRELIMINARYlNONSTERILE DEVICE MADE LONG BEFORE PREAMENDMENTS. USE OF BAG MADE STOMACH HURT AND LEFT REDDISH BURN MARK FROM RECTUM TO LEFT KNEE. DOCTOR IDENTIFIED BURN(S) IN BOWEL AREA. A RED DYE IS EMITTED FROM THE BAG WHEN IN USE.ICAUSE UNKNOWN

GILETTE AVEIIRVINEICA(927141SERIOUS INJURYIXABCIJCARDIOVASCULARILWQIFINALIOUTLET STRUT FRACTURE. NO ADDITIONAL INFORMATION AVAILABLE. MFG DISCLAIMER SUBMITTED. IT APPEARS THAT THE MAIN CAUSE OF VALVE FAILURE WAS FATIGUE. NO METALLURGICAL OR MANUFACTURING DEFECTS RESPONSIBLE FOR THE FRACTURE COULD BE 1DENTIFIED.IMFGPROCEDURE M100138112/24/841SILCON VFL(SILAFILC0N)IDOWCORNIDOW CORNING OPHTHALMICSl4700 COLLEY AVE/NORFOLKIVA123508lSERIOUS INJURYJNAINAIOPHTHALMIClHPXlFINALIPT HAD RIGHT LENS DISPENSED 7/1/84. LENSES WORN SUCCESSFULLY UNTIL 11/19/84. PT CAME TO DR FOR BLURRY VISION. EVALUATION THAT SHOWED 3+ EDEMA AND CENTRAL ABRASION. ABRASION EXTENDED TO ENDOTHELIAL LAYER CAUSING ENDOTHELIAL AND STROMAL SCARRING. GANTRISIN WAS ADMINISTERED; VISION REDUCED TO 20/50+ WITH SPECTACLES. HEALING OF THE RIGHT EYE IS PROGRESSING. WHEN EYE IS HEALED CONTACT LENSES WILL BE TRIED AGAIN. DOCTOR'S OPINION THAT ABRASION CAUSED BY FOREIGN BODY OR OVERWEAR SYNDROME.ICAUSE UNKNOWN R1 O0 155 I 12/27/841RADIATION PROTECTION APRONIMAVIAMERIMAVIG OF AMERICAITORRANCE ST, PO BOX 5681TORRINGTONICTIIMALFUNCTIONIIALL

REPORTING FIRM HAS DOCUMENTS.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO

M100203112/27/841T.A.R.A. HIPIDEPUYIDEPUY INClPO BOX 988IWARSAWJIN1465801SERIOUS

SURGERY WAS PERFORMED AND THE PRODUCT WAS REMOVED.ITHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE. M1002041 12/27/841COMPRESSION ROD 3OOMMISTUADRUGSURGSUPP/STUART/ 1 STUART PLAZA, DONOHUE & LUXOR ROADS~GREENSBURG/PA~15601~MALFUNCTION~~CR1980~ORTHOPEDIC~JDN~FINAL~THE ROD HAD BROKEN SOME TIME AFTER THE OPERATION. DR USED TOO MUCH COMPRESSION AND THE ROD EVENTUALLY BROKE. DID NOT RESULT IN DEATH OR SERIOUS INJURY. (SEE FILE)/THE CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE THE USE OF THE DEVICE. R100205~12/27/84~ANGIOSKOP~SIEMENS~SIEMENS~ 186 WOOD AVE SOUTH~ISELIN~NJ~0883O~MALFUNCTION~~jRADIOLOGICAL~JAA~FINAL~POTENTIAL SAFETY HAZARD WITH THE SIEMENS ANGIOSKOP. ANGIOSKOP IS A STATIONARY C-ARM UNIT WITH PROVISIONS FOR DIRECT AND INDIRECT RADIOGRAPHIC TECHNIQUES. HAS A DUAL IMAGE RECEPTOR. SELECTION IS DONE MANUALLY BY ROTATING THE RECEPTOR ASSEMBLY 90 DEGREES. IN 198 1, FIVE INCIDENTS REPORTED WHERE THE LATCH MECHANISM HAD RELEASED AND CAUSED THE RECEPTOR ASSEMBLY TO ROTATE. ONE PATIENT WAS STRUCK ON THE SIDE OF THE ABDOMEN, UNINJURED. IN 1982, ATTACHED A WARNING LABEL. ON 12/11/84 AN INCIDENT OCCURRED INVOLVING THE FILM CHANGER ON THE

DIVI73 1 CENTRAL AVEIMURRAY HILL(NJI07974/SERIOUS INJURY1121 121GASTROENTEROLOGY-

M100096112/17/84lBJORK SHILEY CONVEXO-CONCAVE SIZE 23JSHILEYISHILEY INC.117600

VARIETIES(RADIOLOGICAL~IWO~PRELIMINARY~APR0NS DEVELOP X-RAY LEAKAGE.

DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

INJURY~~1043-09~0RTHOPEDIC~KWZ~PRELIMINARY~THE ARTHROPLASTY FAILED, REVISION

ANGIOSKOP. PT SUSTAINED INJURIES ON THE RIGHT SIDE OF FACE. OCCURRED DUE TO RELEASE OF HOLDING LATCH DURING ROTATION OF IMAGING ASSEMBLIES. X-RAYS OF PT'S HEAD WERE NEGATIVE. (SEE F1LE)IUSER M100093~12/17/84~PROLENE SUTUREIETHICONIETHICON, INC.IROUTE 221SOMMERVILLEINJ1088761SERIOUS INJURYJ17761GIGENERAL AND PLASTIC SURGERYIGAWIFINALIADVERSE OPHTHALMIC TISSUE REACTION THREE WEEKS POST CATARACT EXTRACTION AFFECTING VISION OF PATIENT. ADDITIONAL INFORMATION UNKNOWN. REPORT WAS GIVEN TO SALES REPRESENTATIVE.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE CAUSE ASSOCIATED WITH THIS TYPE OF EVENT IS USUALLY ATTRIBUTED TO THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF

AND/OR OTHER ACTION IS INDICATED. M10017 1 I12/27/841PLAYTEX SUPER PLUS TAMPONIINTLPLAYIINT'L PLAYTEX12 15 COLLEGE RDIPARAMUSINJ1076521SERIOUS INJURYI"S0RT" SUPER PLUSlNONEIOB/GYNIHILIPRELIMINARYlCORRESPONDENT CLAIMED TOXIC SHOCK SYNDROME. FIRM REPORTER DECLINED TO GIVE IDENTITY AND ADDRESS OF REPORTING ATTORNEY.IOTHER MlO0094112/17/841PDS SURGICAL SUTUREIETHICONIETHICON, INCIROUTE 221SOMMERVILLEINJ1088761SERIOUS INJURYl12529GIGENERAL AND PLASTIC SURGERYIHMOJPRELIMINARY/OPHTHALMIC SUTURE BREAKAGE TWO WEEKS POST OPERATION RESULTING IN REOPERATION FOR CORRECTION. ADDITIONAL INFORMATION UNKNOWN. REPORT WAS GIVEN TO SALES REPRESENTATIVE. NAME AND ADDRESS UNKNOWN.ICAUSE UNKNOWN M100173112/27/841PLAYTEX TAMPONIINTLPLAYIINT'L PLAYTEXl215 COLLEGE RD/PARAMUS~NJ/07652~DEATH~INONE~OB/GYNJHILIPRELIMINARY~CORRESPONDENT REPORTED DEATH DUE TO TOXIC SHOCK SYNDROME.IOTHER M 1 O0 1721 12/27/841PLAYTEX SUPER TAMPONIINTLPLAY/INTERNATIONAL PLAYTEX12 15 COLLEGE RDIPARAMUS/NJ1076521SERIOUS INJURY/"SORT": SUPER/NONEIOB/GYNIHILIPRELIMINARY/CORRESPONDENT CLAIMED TOXIC SHOCK SYNDROME. FIRM CONTACT DECLINED TO IDENTIFY (OR ADDRESS) REPORTING ATTORNEY./OTHER

INC14700 COLLEY AVEINORFOLKIVA123508lSERIOUS INJURYlUAIUAIOPHTHALMICIHPXjFINALISILCON LENSES HAVE BEEN WORN FOR APPROX 3 MONTHS. ON 12/21/84, PT CONTACTED PHYSICIAN STATING ONE LENS BROKE WHILE IN PLACE (ON CORNEA). DISCOMFORT NOTED THE NEXT DAY. PT A D M I n E D TO HOSPITAL AND LENS FRAGMENT REMOVED FROM SCLERA. PRACTITIONER STATED AN ANTIBIOTIC PROBABLY WAS ADMINISTERED AND EYE PATCHED FOR 1 DAY. PT SEEN 12/26/84; THE EYE WAS QUIET AND COMPLETELY HEALED. NEW LENS DISPENSED AT THAT VISIT.ICAUSE UNKNOWN M 1000921 12/17/84IUNKNOWNIETHICONIETHICON INCIROUTE 22/SOMMERVILLEINJ108876~MALFUNCTION~~~GENERAL AND PLASTIC SURGERY/GABIFINALISURGICAL NEEDLE BROKE DURING OPERATION OF FASCIA CLOSURE AND ADDITIONAL OPERATIVE TIME WAS NECESSARY TO RECOVER THE BROKEN NEEDLE. REPORT GIVEN TO SALES REPRESENTATIVE ON 12/12/84.lCAUSE UNKNOWN M 1000091 12/24/84/ WALL MOUNTIGCXIGCX COW] 175 WYMAN ST~WALTHAM/MA1022541MALFUNCTION~78914A178918AICARDIOVASCULAR~DSHlFINALlSEPAR ATION OF SUPPORT HANGER FROM HANGER ARM WHERE THE MEDICAL RECORDER IS SUSPENDED.IUSER

THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP

M100174~12/27/84~SILCON VFL(SILAFILC0N A)IDOWCORN/DOW-CORNING OPHTHALMICS,

M1 O01 851 12/24/84(BLEIER SECU-CLIPIGYNECOLIGYNECOL, INC1785 MAIN ST, SUITE FIAF- MOON-BAY~FL~94019~SERIOUS INJURY/IIOB/GYNIHGBIFINALlDR APPLIED CLIP. PATIENT BECAME PREGNANT. FAILURE OF THE CLIP TO OCCLUDE THE FALLOPIAN TUBE CAN RESULT IN THE PATIENT BECOMING PREGNANT. FAILURE CAN OCCUR FROM

MISPLACEMENT OF THE PRODUCT. ETIOLOGY OF THIS INCIDENT IS UNKNOWN AT THIS TIME.IOTHER M100083~12/17/841SILASTIC MAMMARYIDOWCORNIDOW CORNING COW11635 N GLEANER ROAD~HEMBOCK~MI~48626~MALFUNCTION~~P525043O~GENERAL AND PLASTIC SURGERYIFTRIPRELIMINARYIIMPLANT RUPTURED 9 MONTHS AFTER IMPLANTATION. DOCTOR REMOVED THE 1MPLANT.ICAUSE UNKNOWN M100095112/17/84~BJORK-SHILEY CONVEXO CONCAVE SIZE 291SHILEYISHILEY. INC.117600 GILETTE AVEIIRVINE/CA1927141DEATH129MBRCB10123 (70 DEGREE)IICARDIOVASCULARlLWQIFINALIOUTLET STRUT FRACTURE. NO ADDITIONAL INFORMATION AVAILABLE. UNKNOWN IF PRODUCT WILL BE RETURNED TO MANUFACTURER. WELD DATE WAS 11/30/81. MANUFACTURING DATE WAS 2/17/82.IMFG/PROCEDURE M 1 O00 1 1 11 2/28/841PLAYTEX TAMPONIINTLPLAYIINTERNATIONAL PLAYTEX, INCIPLAYTEX

DETAILS PROVIDED BY FIRMICAUSE UNKNOWN M 1000241 12/17/84ICATHILON IVlCRITIKONlCRITIKON INC14110 GEORGE STREET/TAMPAIFLI336141MALFUNCTION114424 18GAX13/41GENERAL HOSPITALIFOZIPRELIMINARY/PERFORMING VENIPUNCTURE, UPON WITHDRAWING INTRODUCER, HUB OF CATH FELL ON THE FLOOR. UNABLE TO LOCATE CATHETER. SEVERAL SURGICAL PROCEDURES. CLEAR CATHETER NOT VISIBLE. MAY NOT HAVE BEEN A CATHETER ATTACHED TO THE HUB.ICAUSE UNKNOWN M100012112/28/841PLAYTEX SUPER DEODORANT TAMPONIINTLPLAYIINTERNATIONAL PLAYTEX, INCIPLAYTEX PARKlDOVERlDEllSERIOUS INJURYIIIOB/GYNIHILIFINALITOXIC SHOCK SYNDROME - NO OTHER DETAILS PROVIDED BY FIRM.ICAUSE UNKNOWN M100013112/28/841PLAYTEX TAMPONIINTLPLAYIINTERNATIONAL PLAYTEX, INCIPLAYTEX

DETAILS PROVIDED BY FIRM.ICAUSE UNKNOWN M100014~12/28/84~PLAYTEX TAMPONIINTLPLAYIINTERNATIONAL PLAYTEX, INCIPLAYTEX

DETAILS PROVIDED BY FIRM.ICAUSE UNKNOWN M 100022/ 1211 7/841JELCO IV CATHETERlCRITIKONlCRITIKON INClPO BOX 228001TAMPAIFL133622/MALFUNCTION~/~GENERAL HOSPITAL(FOZ/PRELIMINARYIHOSPITAL

REDNESS, 2 HAD PUSTULE FORMATION. CULTURED: 1 STAPH AUREUS. 2 STAPH EPI. HOSPITAL KEEPING CATHETER IN MORE THAN 3 DAYS. NOT RECOMMENDED. 30 SECOND BETADINE PREP. (STANDARD=2 MINUTES). CONSULTANT 1NVOLVED.ICAUSE UNKNOWN M100045~12/21/84JCOMPRESSION TUBE & PLATE 71/4”,135 ANGLElZIMMERlZIMMERlPO BOX

IMPLANTED APRIL 1984 AND REMOVED OCTOBER 1984 BECAUSE OF PLATE FRACTURE. SURGICAL INTERVENTION WAS REQUIRED TO RELIEVE UNANTICIPATED TEMPORARY IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE./THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT

PHYSIOLICAL OR PROCEDURAL FACTORS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M 1 O00 15 11 2/28/841PLAYTEX TAMPONIINTLPLAYIINTERNATIONAL PLAYTEX, INCIPLAYTEX PARKIDOVERIDE//SERIOUS INJURYIIIOB/GYNIHILIFINALlTOXIC SHOCK SYNDROME - NO OTHER DETAILS PROVIDED BY FIRM.ICAUSE UNKNOWN M1 00016/ 12/28/841PLAYTEX TAMPONlINTLPLAY~INTERNATIONAL PLAYTEX, INCIPLAYTEX

FURTHER INFORMATION PROVIDED BY FIRM./OTHER M 1 O0 1 181 12/28/8416 FRENCH PIGTAIL CATHETERlMALLCRITCARElMALLINCKRODTlPO BOX

PARKlDOVERlDEllSERIOUS INJURYII/OB/GYN/HILIFINALITOXIC SHOCK SYNDROME - NO OTHER

PARKIDOVERIDEIISERIOUS INJURYIIIOB/GYNIHILIFINALITOXIC SHOCK SYNDROME - NO OTHER

PARKIDOVERIDEIISERIOUS INJURYIIIOB/GYNIHILIFINALlTOXIC SHOCK SYNDROME - NO

REPORTED 24-48 HRS AFTER VENIPUNCTURE,S IVS INFECTED IN MONTH OF OF NOVEMBER.

708lWARSAWiIN1465801SERIOUS INJURYlll131-7710RTHOPEDIC1HRSIPRELIMINARY~DEVICE

AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY

PARKIDOVERIDEI/SERIOUS INJURY/IIOB/GYNIHIL(FINAL(TOXIC SHOCK SYNDROME - NO

58401ST LOUISIM01631341SERIOUS INJURY~~5604-F101~CARDIOVASCULAR~DQO~FINAL~CAROTID

ARTERIOGRAM WAS TO BE PERFORMED AND CATHETER WAS INSERTED TO INJECT CONTRAST MEDIA. DURING INJECTION, HOLE APPEARED IN SIDE OF CATHETER. INJECTION WAS TERMINATED, CATHETER REMOVED. INJECTION VERY PAINFUL TO PT. PT HAS EXPERIENCED SUBCUTANEOUS SLOUGHING OF THE SKIN. THIS EVENT IS POSSIBLY RELATED TO HOLE IN THE CATHETER AND LEAKING OF THE CONTRAST MEDIA. CO HAS REDUCED THE MAXIMUM PRESSURE RATING FROM 1000 PSI TO 900 PSI FOR THIS CATHETER. LABELING CHANGES HAVE BEEN MADE TO INDICATE THE CHANGE AND A LETTER HAS BEEN SENT TO CUSTOMERS.ICAUSE UNKNOWN V100146112/28/841ULTRAFUGE 701BOEHMANNIBOEHRINGER MANNHEIM DIAGNOSTICS, INC19115 HAGUE RDIINDIANAPOLISIIN146250JSERIOUS INJURY1630-1lNAlCLINICAL CHEMISTRYIJQCIPRELIMINARYICENTRIFUGE EXPLODED IN LABORATORY. DR WAS STANDING OVER THE UNIT AND OBTAINED SEVERAL BRUISES ON THE CHEST. DR DID NOT SEEK MEDICAL HELP. HE STATED IT WAS NOT NECESSARY. FREQUENCY AND SEVERITY ISSUE WILL BE DISCUSSED IN THE 15 DAY REPORT.ISERVICE/MAINTENANCE M1001471 12/29/8412000 ANESTHESIA MACHINEIOHMEDAIOHMEDAIOHMEDA DRIVE, PO BOX

DURING BASIC PROCEDURE. COUNTY MEDICAL EXAMINER STATED NO ONE WAS TO USE OR TOUCH THE EQUIPMENT UNTIL HE WAS PRESENT. FIRM REPRESENTATIVE AND COUNTY MEDICAL EXAMINER DID TAPE RECORDING OF ALL THE SETTINGS. FINDINGS: ETHRANE OK, HALOTHANE AND FORANE OUTSIDE LIMITS. COULD BE SWITCHiVALVE AND MAY BE MIXING OF THE TWO. 10 YEAR OLD MALE PATIENT EXPIRED DURING SURGICAL PROCEDURE TO REMOVE A CYST FROM WRIST. REPORTEDLY, THE CASE WAS COMPLETED WHEN THE ANESTHETIST NOTICED DISCOLORATION OF TONGUE & LIPS. UNABLE TO

7550(MADISON~WI~53707~DEATH~2223~NA~ANESTHESIOLOGY~BSZ~FINAL~TEN-YEAR-OLD DIED

REVIVE THE PT. HALOTHANE FROM THE PIGGY-BACK VERNITROL VAPORIZER WAS USED WITH THE FOLLOWING SETTINGS: 3L N 2 0 FLOW, 3L N20 FLOW, 3L 0 2 FLOW, AND 200 CC 02 VERNITROL FLOW. CHECK-OUT OF MACHINE BY CO REPORTED SATISFACTORY EXPECT: 1) AN OFF-SCALE READING ON RIKEN WAS NOTED WITH THE PIGGY BACK VERNITROL VAPORIZER 2) ONE BUBBLE EVERY 2-3 SECONDS WAS NOTED IN THE MAIN VERNITROL VAPORIZER WHEN PIGGY BACK VAPORIZER WAS ON. MFG DISCLAIMER SUBMITTED.ICAUSE UNKNOWN M 10008 11 1211 7/84JPREFILLED HUMIDIFICATION KITITRAVLABOITRAVENOL LABORATORIES1 1 BAXTER PKWYlDEERFIELDlILl600151SERIOUS INJURYJ12D08021ANESTHESIOLOGYlBTTlFINALIHOSPITAL RESP THERAPY DEPT REPORTED LEAKAGE BETWEEN BOTTLE NECK AND CAP. REPORTED BECAUSE LEAKAGE LEADING TO ALTERATION IN PATIENT CONDITION. HAD TO DRAW ARTERIAL BLOOD GASES AND MAY OR MAY NOT HAVE HAD TO ALTER THERAPY.IMFG/MISCELLANEOUS M1001861 121281841ECT 113 TUBULAR PLATEIZIMMERIZIMMER(P0 BOX 7081WARSAWIIN1465801SERIOUS INJURYI1236-0810RTHOPEDIC/HRSlFINALlPLATE WAS PLACED ON FOREARM. X-RAY EXAMINATION AFTER 2 WEEKS NOTED BENDING WITH SUBSEQUENT REMOVAL OF PLATE DURING 3RD WEEK. PLATE RECEIVED BY CO IN A BROKEN CONDITION. (DEVICE LABEL DOES ADVISE OF BREAKAGE). (SEE FILE FOR PHOTOGRAPHS OF BROKEN DEVICE).lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M 1000281 12/19/841PLASTIPAK LO DOSE/BECTDICK/BECTON DICKINSON,CONSUMER PRODUCTSIP.0. BOX 50001ROCHELLE PARKINJ1076621SERIOUS INJURYlUlOOllGENERAL HOSPITALlFMFIPRELIMINARYlNEEDLE SNAPPED OFF AT HUB. SURGICAL PROCEDURE USED TO REMOVE.(THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE

HAVE BEEN CAUSED BY THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF

AND/OR OTHER ACTION IS INDICATED.

INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY

THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP

M1001871 12/28/841HALL ARTHROTOME FLAT ENDIZIMMERIHALL SURGICAL DIVI1 170 MARK AVENUElCARPINTERIAlCA1930131SERIOUS INJURY~~5039-05~ORTHOPEDIC~HRX~FINAL~TIP OF CUTTER CAME OFF IN SURGICAL SITE DURING ARTHROSCOPY. ARTHROTOMY HAD TO BE PERFORMED TO RETRIEVE PIECE.ITHE CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE THE USE OF THE DEVICE. M1 002061 121281841SINGLE PT DELIVERY SYSTEMIDRAKWILLIDRAKE WILLOCKJ 13520 SE

UROLOGYlFKPlFINALlCO'S SERVICE DEPARTMENT CONTACTED BY THE CHIEF TECHNICIAN OF THE HOSPITAL STATING HOSP NEEDED NEW ROUTING VALVES. THREE PTS SUFFERED FROM SEVERE SODIUM SICKNESS. THIS INTERRUPTED THE DIALYSIS TREATMENT. PROBLEM COULD BE INTERNAL LEAKS IN THE ROUTING VALVE.IMFG/MATERIALS

PHEASANT COURTIPORTLANDIOR1972221SERIOUS INJURY1421511GASTROENTEROLOGY-

M100175)12/28/841CENTRAL SYSTEMIDRAKWILLIDRAKE-WILLOCK DIV OF CD MEDICAL, INC113520 SE PHEASANT COURTJPORTLAND~OR~97222~DEATH~4009-1~~GASTROENTEROLOGY- UROLOGYIFKQIFINALIUNIT USED UP EXISTING CONTENTS OF DIALYSATE CONCENTRATE TRIGGERING ALARM MODE. CHIEF TECHNICIAN TURNED SYSTEM OFF, RESTARTED UNIT. SYSTEM AUTOMATICALLY SWITCHED TO "BY PASS" MODE. NO OTHER DETAILS PROVIDED. FIRST EVENT OF THIS NATURE KNOWN TO REPORTER. ONLY KNOWN DEATH ASSOCIATED WITH SYSTEM USE. SYSTEM WAS BEING USED WITHOUT A REDUNDANT TEMPERATURE/CONDUCTIVITY MONITOR IN PLACE.ICAUSE UNKNOWN V1 O01 191 12/28/841CELL SEPARATOR APHERESIS KITITRAVLABOITRAVENOL LABS1 1 BAXTER PKWYIDEERFIELDIIL160015ISERIOUS INJURYI14R22101HEMATOLOGYIGKTIFINALITWO HEALTHY WHITE CELL DONORS EXHIBITED ALLERGIC REACTIONS WITH FLUSHING AND OTHER SYMPTOMS WHEN APHERESIS WITH PLASMAGEL AND HEPARIN LOADING DOSES. TREATED WITH POLARIMIN AND SOLUMEDROL AND SYMPTOMS WERE RELIEVED WITHIN 30-60 MINUTES. MFG DISCLAIMER SUBMITTED.ICAUSE KNOWN - OTHER V100152/12/20/84~GLUCOMETER~AMES~AMES DIV, MILES LABS, INC.IP. O. BOX 40/ELKHARTIIN/465 15ISERIOUS INJURYl55801/CLINICAL CHEMISTRYICFRIFINALICOMPLAINANT ALLEGES GLUCOMETER AND DEXTROSTIX GIVE LOW READING. TEST READ 57MGIDL WHEN ACTUAL READING WAS 120MGIDL. BLOOD SUGAR NEVER EXCEEDED 8OMGiDL ON GLUCOMETER. CONTROL NOT SPECIFICALLY IDENTIFIED. SAID WAS OUTDATED. CHIP CALIBRATED, THEN REREAD. GOT ACCEPTABLE RESULTS. GOT SICK AND STARTED VOMITING. COMATOSE. ADMITTED TO HOSP WITH BLOOD SUGAR 863MGIDL. CHECKED LAST HERSELF WITH RESULT OF 80MGIDL. BRITTLE, INSULIN DEPENDENT DIABETIC.(USER M100023/12/17/84~CATHILON IVlCRITIKONlCRITIKON INC14110 GEORGE STREETITAMPAIFL133614~MALFUNCTION~~4424 18GAX13/41GENERAL HOSPITALIFOZIPRELIMINARYICATHETER SEPARATED DUE TO PROCEDURAL ERROR. SURGICAL REMOVAL. NOT A PRODUCT PROBLEM.IUSER M100008~12/21/84/1528 MICROFOAM SURGICAL TAPE13M13M13M CENTER, BLDG 270-4A-051ST PAULIMN155 1441SERIOUS INJURYIIIGENERAL AND PLASTIC SURGERYIKGXIFINALIPHYSICIAN APPLIED PRODUCT TO PT. UPON REMOVAL NOTICED REDNESS AND BLISTERS. INJURY NECESSITATED PHYSICIAN APPLYING OINTMENT. PT HAS RECOVERED. THE TAPE PRODUCT WAS APPLIED OVER DRIED SURGICAL SCRUB AND PREP. WHEN REMOVED TWO DAYS LATER PHYSICIAN OBSERVED SMALL BLISTERS AND RED SKIN. PHYSICIAN APPLIED TOPICAL OINTMENT. THE ALLEGED INJURY SPONTANEOUSLY CLEARED. THE INFREQUENT OCCURRENCE OF THIS TYPE OF EVENT REMAINS UNCHANGED./OTHER M1001 531 12121I841PLASTIPAK 1 CC U 1 O0 INSULIN SYRINGE/BECTDICKIBECTON- DICKENSON1365 W. PASSAIC STREETIROCHELLE PARKINJ/076621SERIOUS INJURY1184lOlGENERAL HOSPITALlFMFlFINALINEEDLE BROKE OFF IN RIGHT SIDE. HAD TO GO TO EMERGENCY ROOM FOR SURGICAL REMOVAL. HOSP DISPOSED OF THE NEEDLE.ICAUSE UNKNOWN M100106~12/21/84~AMBULATORY INSULIN PUMPICARDPACEICARDIAC PACEMAKERSJNCIP. O. BOX 640791ST PAULIMNI551641SERIOUS INJURY119lOOlGENERAL HOSPITALIFRNIFINALIPATIENT ADMITTED TO HOSPITAL WITH KETOACIDOSIS. PHYSICIAN ALLEGES UNEXPLAINED

INFUSION PUMP PROBLEMS. HAVE REQUESTED DEVICE. WILL EVALUATE AND SEND COMPLETE REPORT TO FDA.IOTHER M100107112/21/841PLAYTEX TAMPONSIINTLPLAYIINTERNATIONAL PLAYTEX, INC1215

DATA.IOTHER M100154112/21/841REVERSE CUTTING KNIFEIDEPUYIDEPUY, INClPO BOX

DURING ARTHROSCOPIC KNEE SURGERY, BLADE BROKE. CO INVESTIGATION REVEALED THAT EXCESSIVE PRESSURE WAS APPARENTLY USED, WHICH IS CONTRARY TO INSTRUCTIONS IN THE LABELING, CAUSING THE BLADE TO BREAK AND THIS WAS NOT DUE

M100122/12/21/84lTAMPAX TAMPONITAMBRANDSITAMBRANDS, INClBOX 2711PALMERIMA(01069/SERIOUS INJURYIJIOBIGYNIHEBIFINALICUSTOMER REPORTED SYMPTOMS SOME OF WHICH ARE REPORTED BY PEOPLE SUFFERING FROM TOXIC SHOCK SYNDROME. CUSTOMER REQUIRED TWO PERIODS OF HOSPITALIZATION. EXPERIENCES A TEMPERATURE ELEVATION PRIOR TO MENSTRUATION. HOSPITALIZATIONS NOT RELATED TO TSS SYMPTOMS. DURING HER FIRST HOSPITALIZATION, WAS TOLD SHE HAD STAPH INFECTION IN MOUTH. REFERRED TO SPECIALIST IN INFECTIOUS DISEASES./OTHER VlO0134112/21/841COBAS CENTRIFUGAL CHEMISTRY ANALYZERIROCHANALINSTIROCHE

OICLINICAL CHEMISTRYIJJGIPRELIMINARY/WHILE TROUBLESHOOTING A PROBLEM ON DEVICE, OPERATOR WAS CHECKING THE FUSES. IN THE PROCESS OF REPLACING THE FUSE THE OPERATOR RECEIVED AN ELECTRICAL SHOCK AS THE INSTRUMENT WAS STILL PLUGGED IN, AND HE WAS TOUCHING ANOTHER PIECE OF EQUIPMENT. THE OPERATOR WAS TAKEN TO THE HOSPITAL FOR OBSERVATION. ROCHE SERVICE PERSONNEL EXAMINED THE INSTRUMENT TO VERIFY ELECTRICAL SAFETY AND NO IRREGULARITIES WERE NOTED. OPERATORS MANUAL BEING REVISED.IOTHER M100143~12/21/84~POLYFLEX~INTERMEDICS~INTERMEDICS, INClPO BOX

INFECTION AND VENTRICULAR PERFORATION OR ATRIAL PERFORATION. VENTRICULAR LEAD, BUT FIRM IS UNABLE TO IDENTIFY PLACEMENT. BERK STATED THAT NO PERFORATION OF HEART OCCURRED. PATIENT IS FINE. ORIGINAL REPORT OF 12120184 WAS NOT COMPLETED BY DR BERK BUT BY THE CENTRAL SUPPLY DEPARTMENT AT THE HOSPITAL.JOTHER M100006/12/19/84~PETALUMEN T.D. CATHETERlSORERESElSORENSON RESEARCH DIV OF

10ICARDIOVASCULARIDYGIPRELIMINARYIAFTER 4TH INFLATION OF BALLOON, BALLOON RUPTURED. BALLOON USED TO MEASURE WEDGE PRESSURES AND MULTIPLE READINGS WERE BEING TAKEN ON A PT IN THE ICU AT TIME OF RUPTURE. ALTHOUGH NO INJURY OCCURRED, SORENSON RESEARCH'S MEDICAL STAFF ADVISES THAT THE CATHETER MAY BE PLACED IN EITHER THE VENTRICLES OR THE VEINS LEADING TO THE HEART. BALLOON RUPTURE MAY HAVE POTENTIAL FOR SERIOUS INJURY DUE TO FRAGMENTATION AND SUBSEQUENT OCCLUSION OF VEINS.ICAUSE KNOWN - OTHER Ml00007/12/19/84/THERMAL DILUTION CATHETERISORERESEISORENSON RESEARCH DIV OF ABBOTT LABS14455 ATHERTON DRISALT LAKE CITYIUT1841231SERIOUS INJURYINONE/74110- 001CARDIOVASCULARlDYG/PRELIMINARYIBALLOON RUPTURED AFTER BEING IN PATIENT FOR 12 HOURS. BALLOON CATHETER IS USED TO MEASURE THE VOLUME OF BLOOD PASSING THROUGH THE HEART AND MAY BE PLACED IN THE VENTRICLES OF THE HEART OR THE VEINS LEADING TO THE HEART. RUPTURE MAY RESULT IN FRAGMENTATION AND SUBSEQUENT VEIN OCCLUSION. NO INJURY OCCURRED IN THIS CASE.ICAUSE KNOWN - OTHER M100029(12/19/841B.D. PLASTIPAKIBECTDICKIBECTON DICKINSONICONSUMER PRODUCTSIROCHELLE PARK/NJ1076621SERIOUS INJURYlUlOOllGENERAL HOSPITALIFMF1PRELIMINARYINEEDLE BROKE OFF IN PATIENT'S LEG. REMOVED AT

COLLEGE ROADIPARAMUSINJ1076521SERIOUS INJURYI(IOB/GYNIHEBIFINALITSS - NO MEDICAL

9881WARSAWIINIISERIOUS INJURY~~6804-14~0RTHOPEDIC~HTSJFINAL~SURGEON REPORTS

TO ANY MANUFACTURING DEFECT.ICAUSE KNOWN - OTHER

DIAGNOSTIC SYSTIDIV OF HOFFMANN-LAROCHEINUTLEYINJ1071lOlSERIOUS INJURYIIlO-1182-

617(FREEPORT/TX177541 ISERIOUS INJURY1495-03/ICARDIOVASCULAR/DTBIFINALIREPORTED

ABBOTT LABS14455 ATHERTON DRlSALT LAKE CITYIUT1841231SERIOUS INJURYINONE1851 10-

CHILDREN'S HOSPITAL./THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY

M100060~12/21/84~SILICONE-COATED CATHETERICRBARDICR BARD, INCllll SPRING STREETIMURRAY HILLINJ1079741SERIOUS INJURY111657181GASTROENTEROLOGY- UROLOGYIKOD/PRELIMINARYIBALLOON OF CATHETER FAILED TO DEFLATE. PENIS OF PATIENT WAS PUNCTURED WITH HYPODERMIC NEEDLE TO DEFLATE BALLOON. NO SUBSEQUENT PROBLEMS NOTED WITH THE PATIENT AFTER SUCCESSFUL REMOVAL.IOTHER M1000591 12/21/841COUDET CATHETER (RED LATEX)ICRBARDICR BARD, INCIlll SPRING

UROLOGYIEZC1PRELIMINARYlAT TIME OF CATHETER REMOVAL, THE DEVICE FRACTURED INTO SEVERAL PIECES. A CYSTOSCOPE WAS USED TO RECOVER PIECES REMAINING WITHIN

FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

STREETIMURRAY HILLINJ1079741SERIOUS INJURYIIlOlIGASTROENTEROLOGY-

BLADDER. FOURTEEN-YEAR-OLD PATIENT HAD BEEN A PARAPLEGIC AND WAS ROUTINELY CATHETERIZED TO VOID. IN THIS INSTANCE, PATIENT HAD SUSTAINED TRAUMA, BUT CATHETERIZATION WAS PERFORMED ROUTINELY BY PATIENT'S MOTHER. NOT FIRST REPORTED INSTANCE WITH THIS MODEL.ISTORAGE/SHIPPING PROB. M100052/12/19/84~HICKMAN BROVIACICOOKICOOK, INC.IP.0. BOX 4891BLOOMINGTONIIN/47401 IDEATHlllGENERAL HOSPITALILJS/FINAL/CATHETER INSERTED IN

STAFF FOUND CATHETER HAD BEEN SEVERED. REPAIR (USING COOK MANUFACTURED REPAIR KIT) WAS PERFORMED IMMEDIATELY. NO OTHER EVENTS REPORTED CONCERNING

INTRODUCING HYPERAL, CHEMOTHERAPEUTIC AGENTS, BLOOD AND VARIOUS INTRAVENOUSLY ADMINISTERED FLUIDS. THE INFORMATION CONTAINED IN THIS REPORT REPRESENTS KNOWN INFORMATION AT THIS TIME. A REQUEST HAS BEEN MADE TO THE HOSP TO PROVIDE AN AUTOPSY REPORT AND ANY OTHER INFORMATION CONCERNING THIS

72-YEAR FEMALE PATIENT WITH TERMINAL CANCER ON 12 OCTOBER 84. ON 19 NOVEMBER,

CATHETER. PATIENT DIED 2 DECEMBER 84. DOUBLE-LUMEN DEVICE WAS FOR

EVENT. CO WILL FORWARD A FOLLOW-UP REPORT CONCERNING THIS EVENT ONCE IT RECEIVES ADDITIONAL DATA FROM HOSP.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO

MlOOllO~l2/21/84~SPS 350 SINGLE PT SYSTEMITRAVLABOITRAVENOL LABS11 BAXTER

UROLOGYlFKPiFINALlPT BECAME CONFUSED AND DISORIENTED AFTER 3 112 HOURS OF TREATMENT. SERUM SODIUM WAS 116. NO CONDUCTIVITY ALARM SOUNDED. PT HOSPITALIZED AND HAS RECOVERED.ICAUSE KNOWN - OTHER M100109~12/21/84~CAPD SOLUTION TRANSFER SETITRAVLABOITRAVENOL LABS11 BAXTER PKWYIDEERFIELDIIL160015ISERIOUS INJURY115C41601GASTROENTEROLOGY- UROLOGYIKDJIPRELIMINARYIPERITONITIS ASSOCIATED WITH HOLE IN TUBING NEAR SPIKE AFTER FOUR WEEKS USAGE. PATIENT TREATED AND HAS RECOVERED.ICAUSE KNOWN - OTHER M100105112/21/841FETAL MONITORIHEWLPACK/HEWLETT-PACKARD GMBHIlOlO HEWRENBERTER STIBOEBLINGENIFRI/DEATHI8040AIIOB/GYNIKXN/FINALIBABY WAS DEAD

PERFECTLY. NOTE: THE NURSE ACTUALLY USING THE FETAL MONITOR WHEN THIS OCCURRED, DOES NOT RECALL EXACTLY WHICH 8040A WAS INVOLVED.lUSER M100181~12/21/84~INFUSION CONTROLLERlIVAClIVAC CORPORATION~l0300 CAMPUS POINT DRISAN DIEGOICA192121lDEATHI260/IGENERAL HOSPITALILDRIFINALIPT EXPIRED. HOSP THINKS CAUSE MAY BE DUE IN PART TO AN OVERINFUSION OF DRUG STREPTOKINASE. SITUATION INVOLVED 250 CC BAG CONTAINING DRUG TO BE DELIVERED AT 50 CC PER HOUR USING IVAC 260 CONTROLLER. AFTER 1 112 HOURS BAG WAS EMPTY.ITHE CAUSE OF

DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

PKWYIDEERFIELDIIL160015~SERIOUS INJURY/15M13601GASTROENTEROLOGY-

BEFORE DELIVERY - WAS BEING MONITORED BY DEVICE WHICH WAS WORKING

THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY

Ml00113~12/19/84~LIFEPAK SIPHYSCONTIPHYSIO CONTROL COW111811 WILLOWS ROAD/REDMONDIWA198052(DEATH~~~CA~IOVASCULAR~LDD~PRELIMINARY~PARAMEDICS ATTEMPTING TO DEFIBRILLATE PT IN COARSE VENTRICULAR FIBRILLATION. DEFIB WAS REPORTED TO NOT TURN ON AND PATIENT COULD NOT BE DEFIBRILLATED. WILL INVESTIGATE TO SEE IF THERE IS A MALFUNCTION.(CAUSE UNKNOWN M1 O01 821 1212 1/84JVENA CAVA FILTER SYSTEMIMEDITECHIMEDI TECH, INCl480 PLEASANT

284611CARDIOVASCULAR/DTKIFINALISURGEON WAS ADVANCING THE DEVICE SYSTEM OVER A GUIDE WIRE. HE REACHED A POINT OF PHYSICAL OBSTRUCTION IN VASCULATURE, AND WAS UNSUCCESSFUL IN NEGOTIATING THE OBSTRUCTION AFTER MULTIPLE ATTEMPTS. WHEN SYSTEM WAS WITHDRAWN, HE REALIZED THE DEVICE HAD BEEN RELEASED AT AN UNINTENDED LOCATION.ICAUSE UNKNOWN MlOOl15~12/19/84JBJORK-SHILEY CONVEXO CONCAVE/SHILEYISHILEY INC(17600 GILLETTE AVEIIRVINEICA1927141DEATHI/ICARDIOVASCULARlLWQlFINALlOUTLET STRUT FRACTURE. MFG DISCLAIMER SUBMITTED.IMFG/PROCEDURE M 1 O01 3 1 11 211 9/841VALLEYLAB ELECTROSURGICAL GENERATORlVALLEYLABlVALLEYLAB15920 LONGBOW DRIVEIBOULDERICO(803OllSERIOUS INJURYlISSE2L/GENERAL AND PLASTIC SURGERYIGEIIFINALIDURING A LAPAROSCOPY, AN ELECTROSURGICAL SPARK CAUSED A BOWEL PERFORATION NECESSITATING SURGICAL REPAIR OF THE BOWEL. GENERATOR IN USE DURING THE PROCEDURE WITH A WOLF LAPAROSCOPE. INFORMATION SUGGESTS USER PLUGGED THE LAPAROSCOPE INTO THE MONOPOLAR JACK, SHOULD HAVE BEEN IN THE BIPOLAR JACK, A MISUSE OF THE SYSTEM SETUP. GENERATOR NORMALLY ORGINATED SPARK TO BE DELIVERED BY LAPAROSCOPE.IUSER M100051~12/19/84~UNIVERSAL (FEMORAL) HEADlOSTEONICSlOSTEONICS159 ROUTE

MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

STIWATERTOWNIMA102172ISERIOUS INJURY/JV2-

171ALLENDALEINJ107401lSERIOUS INJURYINONEIUHI-5OIORTHOPEDICIKWYIFINAL/FEMALE PT TWISTED OFF KITCHEN STOOL, LEAVING LEG EXTERNALLY ROTATED. X-RAY CONFIRMED DISASSEMBLY OF THE REDUCED PELVIFEMORAL ARTICULATION 33 MOS AFTER PROSTHESIS IMPLANTATION. THE UHMWPOLYETHYLENE RING OF THE FEMORAL COMPONENT WITHIN THE ACETABULAR COMPONENT AFTER FINAL JOINT REDUCTION AND OPERATIVE CLOSURE DISLOCATED COMPLETELY FROM ACETABULAR CUP. OPERATIVE SITE WAS REVISED IMMEDIATELY, WITH NEW COMPONENTS SUBSTITUTED FOR FREE PROXIMAL PARTS. THE COMPONENT'S RETAINING RING CAME FREE FROM THE HEAD AND SLIPPED DOWN ONTO THE NECK OF THE STEM; PROBABLY FOLLOWING DISLOCATION OF THE HIP. THE EVENT INVOLVED ONE PATIENT AND OCCURRED ON 12/07/84. FOLLOWING THE EVENT, THE PATIENT HAD THE COMPONENT SURGICALLY REVISED TO A SIMILAR

REQUIRED SURGICAL INTERVENTION OR REVISION OF THE 1MPLANT.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT

DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY

M1001 14/12/19/841N.B.I.H BIPOLAR TEMP PACEMAKER PROBE/UNITSTATCATHINSTlUSCI DEVISION OF CR BARD INCl129 CONCORD ROADlBILLERICAlMAlOl82 1 ISERIOUS INJURY~007406~007406~CARDIOVASCULAR~LDF~FINAL/CATHETER USED TO PACE PATIENT'S HEART FOR 24 HOURS WITHOUT INCIDENT. MONITOR NOTICED BEGINNING OF ARRHYTHMIA IN MONITORING. MD DETERMINED THAT CATHETER SHOULD BE REPLACED. NEW CATHETER PACED ADEQUATELY. PERMANENT PACEMAKER IMPLANTED 3 DAYS LATER.ICAUSE UNKNOWN

COMPONENT. THUS, THE EVENT INVOLVED "SERIOUS INJURY" - BY MDR DEFINITION - AS IT

AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE

MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED,

M1000541 12/20/84~PACEMAKERJCORATOMIC~CORATOMIC INC1300 INDIAN SPRINGS ROADlINDIANAlPAll5701 ISERIOUS INJURYlL500/ICARDIOVASCULARIDXYIFINALIPRIOR TO CLASS I11 RECALL, CONDUCTED ON MODEL L500 CONSIDERED COMPLETE AS OF 4 NOVEMBER 81. RETURNED BY HOSPITAL WITH REQUEST FOR ANALYSIS FOR POSSIBLE

YEAR LIFE. NO REASON AT THIS TIME TO SUSPECT PREMATURE EXPLANTATION. THIS IS NOT THE FIRST UNIT RETURNED FOR THIS REASON. DEVICE HAS BEEN TESTED AND FOUND TO HAVE NO OUTPUT. PROBLEM HAS BEEN DETERMINED TO BE THE BATTERY.ICAUSE

M100041 I121201841PULSE GENERATORICOOKPACE(CO0K PACEMAKER CORpIP.0. BOX 5291LEECHBURG/PAIl56561SERIOUS INJURYI327TIICARDIOVASCULARIDXYIFINALIPACEMAKER IMPLANTED ON 12/7/84. EXPLANTED ON 12/8/84 AND RETURNED FOR EVALUATION. PHYSICIAN WHO DID IMPLANTATION REPORTED IT AS A MALFUNCTION OF THE PACEMAKER. CO INSPECTED PACEMAKER AND FOUND THE DEVICE TO BE WITHIN SPECIFICATIONS OF LABELING. SURGICAL INTERVENTION TO EXPLANT PACEMAKER USING A DIFFERENT UNIT FROM A DIFFERENT PACEMAKER COMPANY. ECG STRIPS PROVIDED TO THE CO INDICATED THAT THE PULSE GENERATOR AND LEAD WERE WORKING PROPERLY ON THE DAY OF IMPLANT. HOWEVER, ON 12/08/84 (THE NEXT DAY), THE STRIPS INDICATED 2 NON-SENSED R-WAVES AND A PACED STIMULUS THAT DID NOT CAPTURE THE RIGHT VENTRICLE. THE MFG CONCLUDES THAT THE PULSE GENERATOR AND HEART LEAD WERE TESTED AND FOUND TO BE WITHIN SPECIFICATION. A COPY OF OUR TECHNICAL REPORT IS ATTACHED. THE CONCLUSION REACHED WAS THAT THE HEART LEAD TIP ELECTRODE BECAME DISLODGED FROM THE ENDOCARDIUM.IUSER M100055~12/20/84~0VALITH PACEMAKERlCORATOMICICORATOMIC INC1300 INDIAN SPRINGS ROADIINDIANAIPAI 157011SERIOUS INJURYIP2IJCARDIOVASCULARlDXYlFINALIUNIT RETURNED FOR ANALYSIS OF POSSIBLE DROP IN PACING RATE. NOT THE FIRST UNIT RETURNED FOR

(BATTERY) DEPLETION. UNIT SHIPPED FROM FIRM 8 DECEMBER 77, WARRANTEED FOR TEN-

KNOWN - OTHER

THIS REASON. UNIT HAD REACHED END-OF-LIFE DUE TO A DECLINE IN BATTERY PERFORMANCE. NO STATEMENT HAS BEEN MADE IN CORATOMIC'S LABELING TO COVER EXPLANTS OF THIS NATURE.ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED. M1000561 12/20/84/OVALITH PACEMAKERlCORATOMIClCORATOMIC INC1300 INDIAN SPRINGS ROAD/INDIANAIPAI 157011SERIOUS INJURY(920I/CARDIOVASCULARIDXYIFINAL/UNIT EXPLANTED DUE TO INFECTION AT IMPLANTATION SITE OR POSSIBLE ALLERGIC REACTION. FIRM DID ELECTRICAL CHECK ON UNIT; NO PROBLEMS WERE FOUND. A LOT CHECK WAS PERFORMED ON UNITS BRACKETING THIS SERIAL NUMBER, AND NO OTHER INFECTION PROBLEM REPORTS WERE DISCOVERED. NO STATEMENT HAS BEEN MADE IN CORATOMIC'S LABELING TO COVER EXPLANTS OF THIS NATURE.IOTHER M100132112/20/84)HARRINGTON ASSEMBLY 7 1/2"1ZIMMERIZIMMERIP.O. BOX 708IWARSAW1Ih1465801SERIOUS INJURYl177-5508IORTHOPEDICIJDN~PRELIMINARY~DEVICE WAS FOUND FRACTURED 1/31/83. DEVICE WAS NOT RETURNED AND NO ADDITIONAL INFORMATION IS AVAILABLE. INFO RECEIVED BY LEGAL DEPT. AS NOTICE OF LEGAL CLAIM ON OR ABOUT 12/18/84.1THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE CAUSE ASSOCIATED WITH THIS TYPE OF EVENT IS USUALLY ATTRIBUTED TO THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE

INDICATED. M1 O 0 1361 12/2 1/84lMULTILUMEN CATHETERIARROWIARROW INTERNATIONAL, INCIHILL AND GEORGE AVElREADINGlPAl196101DEATHIIICARDIOVASCULARlDQOIFINALlDEATH OCCURRED FROM TAMPONADE SECONDARY TO RIGHT ATRIAL PERFORATION. ATTORNEY FOR HOSP INDICATED THERE WAS NO PRODUCT MALFUNCTION. ATTORNEY REQUESTED INFORMATION CONCERNING THE PROCEDURE, WHICH WILL BE FURNISHED BY FIRM.

PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS

PATIENT DIED FROM TAMPONADE SECONDARY TO RIGHT ATRIAL PERFORATION. INFORMATION FORWARDED TO ARROW BY MR ROGER STUART, ATTORNEY FOR OKLAHOMA MEMORIAL HOSPITAL. IF YOU NEED ANY ADDITIONAL INFORMATION, WE CAN UNDOUBTEDLY OBTAIN IT FROM MR STUART BUT HE HAS INDICATED THAT THERE WAS NO PRODUCT FAILURE OR MALFUNCTION, AND THE HOSPITAL IS CONTENDING THAT RIGHT ATRIAL PERFORATION IS A ONE OF THE POTENTIAL COMPLICATIONS OF CENTRAL VENOUS CATHETERIZATION.IUSER M1000571 12/20/8410VALITH PACEMAKERlCORATOMIClCORATOMIC INCJ300 INDIAN SPRINGS ROAD~INDIANA~PA~15701~0THER~P~~CARDIOVASCULAR~DXY~F~AL/UNIT RETURNED WITH REQUEST FOR ANALYSIS. ELECTRICAL CHECK REVEALED NO PROBLEMS. PACEMAKER WAS WITHIN ITS NORMAL PERFORMANCE CURVE FOR THIS MODEL. THIS IS NOT THE FIRST UNIT OF THIS MODEL RETURNED WITH NO APPARENT FAULT. FIRM SATES THAT HOSP ERRED IN RETURNING ADEQUATELY FUNCTIONAL UNIT AND BELIEVES IF ANY "SERIOUS INJURY" OCCURRED (NONE WAS REPORTED EXPLICITLY TO MFG.) IT CANNOT BE ATTRIBUTABLE TO THIS PULSE GENERATOR, PER SE. NO STATEMENT HAS BEEN MADE IN CORATOMIC'S LABELING TO COVER EXPLANTS OF THIS NATURE.IOTHER MlOOl17/12/21/84~SUPERFLOW CATHETERlCORDISlCORDIS COW110555 WEST FLAGLERIMIAMIIFL133 172ISERIOUS INJURY115285 1OlCARDIOVASCULARlDQO~FINAL~TIP OF A PIGTAIL CATHETER BROKE OFF IN A PT'S FEMORAL ARTERY. CATHETER TIP WAS SURGICALLY REMOVED WITHOUT ANY COMPLICATION. PT HAD UNDERLYING SEVERE CIRCULATORY PROBLEMS. CATHETER INSERTED TO PERMIT INJECTION OF STREPTOKINASE TO DISSOLVE THROMBUS. PT HAD SCLEROSED VESSELS. THIS CONDITION CREATED GREAT RESISTANCE IN INSERTING AND WITHDRAWING THE CATHETER. EXCESSIVE FORCE CAUSED TIP TO BE BROKEN OFF. (SEE F1LE)IUSER MlO0183~12/21/84~COMPRESSION HIP SCREW PLATE6" X 1351RICHMEDI/RICHARDS MEDICAL

5719110RTHOPEDICIHRSIFINALlFIRM INFORMED PLATE BROKE NEAR APEX. HAD TO BE REPLACED 3 WEEKS AFTER IMPLANTED. SOME QUESTION OF PT FOLLOWING DRS INSTRUCTIONS ABOUT WEIGHT BEARING. PT OVERWEIGHT MALE. BREAKAGE OF THIS TYPE FIXATION DEVICE OCCURS IN SOME INSTANCES INVOLVING EAFUY WEIGHT BEARING. RESULT OF EVALUATION WILL BE PROVIDE WHEN AVAILABLE.ICAUSE UNKNOWN M1000461 12/2 1/84/TRAV-X-CHANGE CONNECTION DEVICEITRAVLABOITRAVENOL LABS, INC/ 1

UROLOGY/KDJ~FINAL/PERITONITIS ASSOCIATED WITH HOLE IN TUBING FROM ROUGH AREA

COJ1450 BROOKS RDIMEMPHIS/TN1381161SERIOUS INJURYll2-

BAXTER PARKWAY/DEERFIELD/IL160015/SERIOUS INJURYI/SC41931GASTROENTEROLOGY-

ON TRAV-X-CHANGE - RETAINER. PATIENT HAS BEEN TREATED AND RECOVERED. MFG DISCLAIMER SUBMITTED.ICAUSE KNOWN - OTHER Ml00184112/21/84/LAG SCREWIRICHMEDIIRICHARDS MEDICAL CO11450 BROOKS RDIMEMPHISITN138116/SERIOUS INJURY/IJORTHOPEDICIHWC/FINALlINFORMED BY ATTORNEY THAT 84-YEAR-OLD FEMALE FELL DOWNSTAIRS. LAG SCREW BROKE. DR REFUSES TO GIVE OUT ANY FURTHER INFORMATION. MUST CONTACT ATTORNEY. DR STATED MOST LIKELY

UNION OF THE FRACTURE SITE.IUSER M100135/12/21/84/SOFLENS POLYMACONNARIOUS SOLUTIONSlBAUSLOMBlBAUSCH & LOMBll400 N GOODMAN STlROCHESTERlNYl14692/SERIOUS INJURYJ44IIOPHTHALMICILPNIFINALILETTER FROM PATIENT: DR CHARACTERIZED AS A MODERATE TO SEVERE EPITHELIAL REACTION. TREATMENT: EYE PATCHED, USED STEROID

NO ATTEMPT TO CONTACT PHYSICIAN OR PATIENT. IMPLIES AN INTERRUPTION OF EPITHELIUM. FIRM CONTACT STATES CONDITION SHOULD DISAPPEAR WITH CESSATION OF WEARING LENS. MFG DISCLAIMER SUBMITTED.JUSER

CAUSE OF THE PIN BREAKING WAS THE FALL, AND THAT X-RAYS REVEALED A FIBROUS

DROPS. WILL WAIT 2-3 WEEKS BEFORE GOING BACK ON LENSES. DISCUSSION WITH FIRM:

M 1000421 1212 Il84JBI-ARTICULAR ACETABULAR CUPlZIMMERlZIMMERlPO BOX 7081WARSAW1INJ465801SERIOUS INJURY115096-4610RTHOPEDICII(WAIFINAL/CUP DISLOCATED FROM PATIENT'S ACETABULUM REQUIRING SURGICAL INTERVENTION TO RELIEVE UNANTICIPATED TEMPORARY IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY

STRUCTURE. SURGEON IMPLANTED SECOND (5096-46) ACETABULAR CUP. PHOTOGRAPHS OF THE CUP REVEAL NO DAMAGE. (SEE FILE FOR PHOTOGRAPHS).ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO

M100142/12/20/841SILASTIC GEL FILLED MAMMARY IMPLANTlDOWCORNlDOW CORNING

SURGERYlFTRlFINALlPOSTOPERATIVE RUPTURE APPROX 13 MONTHS AFTER IMPLANTATION (7/14/83) LED TO AN OPERATION OCCURRING 8/8/84. NO STATEMENT OF INJURY NOR OF THE CONDITION OF THE PATIENT. LABELING FOR THIS DEVICE INDICATES THE POSSIBILITY OF RUPTURE UNDER EXTREME CONDITIONS. THERE WAS NO INDICATION OF AN EXTREME CONDITION REPORTED WITH THIS INCIDENT. DEVICE RETURNED WITH SUPPORTING DOCUMENTS.ICAUSE UNKNOWN M100141~12/20/84~SILASTIC GEL FILLED IMPLANT 235 CClDOWCORNlDOW CORNING CORpIP.0. BOX 127)HEMLOCKIMI148626lSERIOUS rNJURYIIP-9741GENERAL AND PLASTIC

IMPLANTATION LED TO AN OPERATION. NO STATEMENT OF INJURY NOR CONDITION OF THE PATIENT WAS INCLUDED AT THIS TIME. LABELING INDICATES POSSIBLILTY OF RUPTURE UNDER EXTREME CONDITIONS. THERE WAS NO INDICATION OF AN EXTREME CONDITION.ICAUSE UNKNOWN M100144~12/21/84~POLYFLEX~INTERMEDICS~INTERMEDICS, INCIPO BOX 6171FREEPORTITX177541lSERIOUS INJURY1483-041/CARDIOVASCULAR(DTBIFINALlINFECTION AND VENTRICULAR PERFORATION OR ATRIAL PERFORATION. AN ATRIAL LEAD, BUT FIRM IS UNABLE TO IDENTIFY PLACEMENT. DR BERK STATED THAT NO PERFORATION OF HEART OCCURRED. PATIENT IS FINE. ORIGINAL REPORT OF 12/20/84 WAS NOT COMPLETED BY DR BERK BUT BY THE CENTRAL SUPPLY DEPARTMENT AT THE HOSPITAL.IOTHER

DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

CORPIP.0. BOX 1271HEMLOCKIMI148626/SERIOUS INJURYIP-993IlGENERAL AND PLASTIC

SURGERYIFTRIFINALIPOST-OPERATIVE RUPTURE APPROX 106 MONTHS AFTER

M 1 O0 1371 12/2 1/841SURGITEK FLEXI-ROD PENILE IMPLANTlMEDIENGIlMEDICAL ENGINEERING COW13037 MT PLEASANT STIRACINE/WI1534041SERIOUS INJURY1100304/GASTROENTEROLOGY- UROLOGYIFAEIFINALIFLEXI-ROD BROKE IN PATIENT REQUIRING SURGICAL INTERVENTION TO RELIEVE UNANTICIPATED TEMPORARY IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE.ICAUSE UNKNOWN M100133~12/20/84~INTERTROCHOTERIP PLATElZIMMERlZIMMERlP.0. BOX

IMPLANTED IN JUNE 1984 AND WAS REMOVED AUGUST 1984, DUE TO BREAKAGE. NO OTHER INFORMATION AVAILABLE. PLATE IS A TEMPORARY FIXATION DEVICE. BREAKS USUALLY

PIECES EXAMINED. VISUAL AND LOW POWERED OPTICAL METALLOGRAPHIC EXAMINATIONS OF THE PLATE REVEALED SCRATCHES ON THE LATERAL SURFACE AND CREVICE CORROSION IN THE COUNTERSINK SCREW HOLES OF THE PLATE. MECHANICAL DAMAGE IN THE FORM OF BURNISHING WAS ALSO OBSERVED ON THE FRACTURE SURFACES OF THE PLATE. IT IS CONCLUDED THAT THE THE PLATE FRACTURED TO TO METAL FATIGUE. (SEE FILE).ITHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE. M1000431 12/2 ll841BI-ARTICULAR ACETABULAR CUPIZIMMERIZIMMERIPO BOX

7081WARSAWIIN1465801SERIOUS INJURY~~458-00-09~ORTHOPEDIC/HRS~FINAL~THE PLATE WAS

ON FEMUR. PT IS 74-YR-OLD FEMALE. FRACTURED 7/8 INCH FROM PROXIMAL END. BOTH

7081WARSAW1IN1465801SERIOUS INJURYl15096-4410RTHOPEDICIKWA~FINAL~CUP DISLOCATED FROM COMPANION FEMORAL COMPONENT 6028-24 REQUIRING SURGICAL INTERVENTION TO RELIEVE UNANTICIPATED TEMPORARY IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. SURGEON IMPLANTED SECOND 5096-44 ACETABULAR CUP. DOCUMENTARY PHOTOS SHOW THAT THE CUP WAS DAMAGED BOTH INSIDE AND OUT - POSSIBLY AT REMOVAL. (SEE FILE FOR PHOTOS).ITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP

MlOO139~Ol/O5/85~MICROVOLUME IV SETlAUTOSYRIlAUTOSYRINGElLONDONDERRY TPKIHOOKSETTINH103106~SERIOUS INJURY1 I [GENERAL HOSPITALlFPAlFINALlLEAKAGE OF INSULIN AT JUNCTION OF TUBING TO HUB. HUB IS PORTION OF IV SET THAT CONNECTS TO THE SYRINGE. LEAKAGE OF INSULIN CAUSED BLOOD SUGAR TO GO OVER 800. PATIENT TREATED IN A STANDARD MANNER. ICAUSE UNKNOWN

RlOO217~Ol/O2/85~KOORDINAT KOMBI TABLEISIEMENSISIEMENS MEDICAL SYSTEMS1186 WOOD AVE S~ISELIN~NJ~08830~MALFUNCTION~GOO6E~ lRADIOLOGICALlIXRlFINAL~SERVICE SUPERVISOR REPORTED THAT AN INCIDENT HAD OCCURRED INVOLVING THE KOORDINAT KOMBI TABLE. THE STEPPING DEVICE WAS ENGAGED AND WHEN THE TABLE REACHED THE LAST POSITION, THE TABLE TOP, WITH PATIENT, TILTED AND PT FELL HEAD END FIRST TO THE FLOOR. THE PATIENT WAS NOT SERIOUSLY INJURED. INCIDENT BEING INVESTIGATED BY THE FACTORY.lUSER

MlOO218~Ol/O2/85~FOREGGER F-100 ANESTHESIA MACHINEIPURIBENNIPURITAN BENNETT CORP19401 INDIAN CREEK PARKWAYIOVERLAND PARKIKS1662251MALFUNCTIONIF-1001 lANESTHESIOLOGYlBSZlFINALlBOTH NITROUS OXIDE YOKE CHECK VALVES WERE FOUND TO BE LEAKING. THESE WERE REPLACED. MACHINE CHECKED TO FACTORY SPECIFICATIONS.~THIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED.

M100220~01/02/85~LIC ANESTHESIA MACHINEIPURIBENNIPURITAN BENNETT CORP19401 INDIAN CREEK PKWYIOVERLAND PARKIKS1662251MALFUNCTIONl I IANESTHESIOLOGYIBSZ(FINALlP0P-OFF VALVE ON ANESTHESIA VENTILATOR WAS LEAKING. THE VALVE WAS REBUILT. THE MACHINE MEETS FACTORY SPECIFICATIONS.lTHIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED.

MlOOl77lOl/O2/851PACEMAKER VX5ICORATOMICICORATOMIC INC1300 INDIAN SPRINGS

2051 ~CARDIOVASCULAR~DXYIFINALlDEVICE RETURNED WITH REQUEST TO CLEAN AND ROAD~INDIANA~PA~l570l~SERIOUS INJURYIVXS-

ANALYZE. THERE IS NO CAPTURE AND NO PULSE-WIDTH SPIKE. ANALYSIS CONFIRMED-NO OUTPUT SECONDARY TO A FAULTY MAIN HYBRID CHIP.IMFG/MISCELLANEOUS

M100176101/02/85/HPF 100 HEMODIALYZERlERIKAlERIKAIl ERIKA PLAZAlROCKLEIGHlNJlO7647lSERIOUS INJURY] 101-90511GASTROENTEROLOGY- UROLOGY~FJI~FINAL~UPON INITIATION OF HEMODIALYSIS, FEMALE PT COMPLAINED OF TINGLING ALL OVER AND SHORTNESS OF BREATH, WHICH QUICKLY PROGRESSED TO RESPIRATORY AND CARDIAC ARREST. PATIENT WAS REVIVED, BUT STILL UNDER OBSERVATION IN INTENSIVE CARE UNIT. STATUS: SERIOUS CONDITION AFTER 8 DAYS IN ICU. NOT THE FIRST SUCH EVENT WITH THIS DEVICE. NO FURTHER ACTION BY THE FIRM IS ANTICIPATED.ICAUSE UNKNOWN

M100219~01/02/85~LIC ANESTHESIA MACHINEIPURIBENNIPURITAN BENNETT CORP19401 INDIAN CREEK PKWYIOVERLAND PARKlKS1662251MALFUNCTIONl I lANESTHESIOLOGYlBSZlFINALlNITROUS OXIDE FLOW CONTROL WOULD NOT COMPLETELY SHUT OFF. FLOW CONTROL WAS ADJUSTED.ITHIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED.

MlOOl88~Ol/O2/85~AUTIMA IIlTELECTRONICSlTELECTRONICS, INCllOl INVERNESS DR, EAST~ENFLEWOOD~C0~80112~MALFUNCTION~2291~ lCARDIOVASCULARlDXYlFINAL12 COMPLAINTS WITH DEVICE: 1. DID NOT HAVE A MAGNET RATE 2. UNABLE TO BE PROGRAMMED FROM THE DDD MODE TO THE W I MODE. DEVICE WILL BE EVALUATED WHEN RECEIVED. MFG DISCLAIMER SUBMITTED.~THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

V100048~01/04/85~GLUCOMETER~AMES~AMES COMPANY11127 MYRTLE STIELKHARTIIN1465141SERIOUS INJURY155801 ICLINICAL CHEMISTRYlCFRlFINALlTHE PERSON USING THE GLUCOMETER TO MEASURE BLOOD GLUCOSE AND TO ADJUST INSULIN DOSE WAS ADMITTED TO THE HOSPITAL TO GET DIABETES UNDER CONTROL AND AT THAT TIME THE GLUCOMETER DID NOT AGREE WITH LAB RESULTS. (E.G., GLUCOMETER 1 0 0 MG/DL vs 300 MG/DL LAB RESULT.) PT WAS NOT RUNNING NORMAL CONTROLS ON THIS DEVICE. PATIENT IS A 25-YEAR-OLD BRITTLE DIABETIC AND NORMALLY TAKES INSULIN 3X/DAY. DEVICE PURCHASED 1/11/84, HAS A ONE YEAR WARRANTY. RETURNED GLUCOMETER PERFORMED WELL. RETURNED DEXTROSTIX WERE VERY BROWN IN COLOR, INDICATING EXPOSURE OT MOISTURE AND/OR HEAT.lCAUSE KNOWN - OTHER

M100050)01/07/85~8 MM MEDI-SPEC FLEXIBLE VACUUM CURETTElCRYOMEDICSlCRYOMEDICS, INC., MEDI-SPEC DIVISION1500 BOSTWICK AVEIBRIDGEPORTICT1066051SERIOUS INJURY1 109F3081OB/GYNIHHKIFINALlDURING A VACUUM CURETTAGE, THE DISTAL PORTION (1 C M ) OF A CATHETER BROKE FROM THE SHAFT AND BECAME EMBEDDED IN THE PATIENT'S MYOMETRIAL WALL. IT REQUIRED A LAPAROTOMY TO REMOVE THE 1 CM OF CATHETER THAT HAD BROKEN OFF. MANUFACTURED BY MEDI-SPEC INC, PACHERO, CALIFORNIA 94533 IN MARCH OF 1984 PRIOR TO CRYOMEDICS ACQUISTION OF THE PRODUCT LINE.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

MlOOl78~Ol/O3/85~LIPPES LOOPlORTHPHARlORTHO PHARMACEUTICALIROUTE 2021RARITANINJ108869lSERIOUS INJURY1 I lOB/GYNIHDTIFINALICONSUMER REPORTED BLEEDING, ECTOPIC PREGNANCY, SEVERE ABDOMINAL PAIN AND OVARIAN CYSTS REQUIRING SURGERY. LIPPES LOOP IN PLACE FROM 1968-74, DURING WHICH TIME COMPLAINTS OCCURRED. DURING 1980, PT UNDERWENT ADDITIONAL (UNSPECIFIED) SURGERY. ICAUSE UNKNOWN

2

MlOOl2O~Ol/O3/85~INFUSION CONTROLLERlIVAClIVAC CORP110300 CAMPUS PT DRIVEISAN DIEGOICA1921211SERIOUS INJURY12601 ]GENERAL HOSPITAL~LDR~FINAL~AT 7 AM, STARTED IV USING TRAVENOL ADMIN SET WITH 1 0 0 CC D5W AT A RATE OF 30CC/HOUR. AT 7:30 CHANGED ADMIN SET TO IVAC SET USED IN CONJUCTION WITH IVAC 260 CONTROLLER. ONLY CHANGED SET BETWEEN FLUID CONTAINER AND FILTER, NOT IV NEEDLE. AT 8 AM NOTICED FLOW STATUS OF THE 260 WAS ALL THE WAY TO THE LEFT IN GREEN INDICATING NORMAL FLOW STATUS (NO ALARM). NURSE DISCOVERED THAT THERE WAS A SEVERE INFILTRATION. ELEVATED PT'S HAND, NEXT DAY SWELLING DECREASED, PT HAS COMPLETE USE OF HAND. HOSP WILL BE RETURNING UNIT FOR TESTING. MFG DISCLAIMER SUBMITTED.~CAUSE UNKNOWN

MlOOO65lOl/O7/85~CARDIAC PACING LEADIMEDTRONICIMEDTRONIC/6970 CENTRAL AVE NE, PO BOX 14531MINNEAPOLISIMNI55443~SERIOUS INJURY/ I ~CARDIOVASCULAR~LDF~FINAL~A PHYSICIAN STRETCHED THE LEAD TRYING TO EXPLANT THE LEAD. HE WAS PULLING ON THE LEAD AND IT WOULDN'T COME OUT SO HE CUT IT OFF. THE WIRE THAT REMAINED IMPLANTED FLOATED DOWN TO THE ATRIUM AND PERFORATED THE RIGHT ATRIUM CAUSING CARDIAC TAMPONADE. PT UNDERWENT SURGERY AND THE WIRE WAS REMOVED. MFG DISCLAIMER SUBMITTED. USER MlOOO49~Ol/O4/85~MODULUSI ANESTHESIA MACHINEIOHMEDAIOHMEDAIOHMEDA DR, PO BOX 75501MADISONIW1153707\SERIOUS IN JURY^ I ~ANESTHESIOLOGY~BSZ~FINAL~PATIENT SUFFERED PHYSICAL IMPAIRMENT AND MENTAL INJURY. PATIENT REPORTEDLY RECEIVED AN OVERDOSE OF ANESTHETIC GAS DELIVERED WHILE UNDERGOING MINOR SURGERY. REPORTED THAT THE MACHINE DID NOT FAIL. REPORTED NO MACHINE MALFUNCTION. MFG DISCLAIMER SUBMITTED.lTHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE.

V100157 101/03/851EXTERNAL PLATELET STORAGElTRAVLABOlTRAVENOL LABS11 BAXTER PKWYIDEERFIELDIIL160015~SERIOUS INJURY1 14R22301HEMATOLOGYIGKT/FINALlDEVELOPED SEPSIS FOLLOWING TRANSFUSION OF SAME PLATELET PRODUCT DIVIDED BETWEEN TWO BAGS OF THE APHERESIS KIT. BOTH PATIENTS HAVE RECOVERED.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. INFORMATION INDICATES THAT THE MEDICAL DEVICE DID NOT MALFUNCTION AND THAT THE INCIDENT WAS NOT ATTRIBUTABLE TO THE DEVICE.

RlOOO72~Ol/O4/85~RADIATION PROTECTION APRONIMAVIAMERIMAVIG195 WOLCOTT ST, PO BOX 5681TORRINGTONICTI IMALFUNCTIONI I ~RADIOLOGICAL~IWO~PRELIMINARY~APRONS MARKED INSIDE AS 0.5 MM LEAD EQUIVALENT. THEY ARE NOT 0.5 MM LEAD EQUIVALENT. HOSPITAL COMPLAINED THAT APRONS HAD HOLES IN THEM. BURKHART- ROENTGEN TOLD HOSPITAL TO WRITE A LETTER, HOLD APRON AND THEY WOULD PICK UP BOTH. MAVIG MISREPRESENTED BURKHART AND PICKED UP LETTER AND APRON./THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW- UP AND/OR OTHER ACTION IS INDICATED.

3

M100074~01/04/85~CALA, LAPAROSCOPIClKARLSTORENDOAMERlKARL STORZ ENDOSCOPYllOlll W JEFFERSON BLVDICULVER CITYICA190232)SERIOUS INJURY1 126172-CJlOB/GYNIHETlFINALlPORTION OF DIGITAL END OF LAPAROSCOPE CANNULA BROKE OFF DURING LAPAROSCOPY SURGERY. SMALL INCISION WAS PERFORMED TO RETRIEVE PIECE. PATIENT RECOVERING WELL.~THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE INFORMATION IN THIS REPORT AND/OR ITS FOLLOW-UP SUGGESTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

Ml00236101/07/85lGAMBRO UDM-10IGAMBROIGAMBRO INC1600 KNIGHTSBRIDGE PKWY~LINCOLNSHIRE~IL~60069~SERIOUS INJURY1 IUDM-1OIGASTROENTEROLOGY-

EXAMINE EQUIPMENT USED TO TREAT TWO PTS. AFTER PTS WERE TREATED WITH THE MACHINE IN THE ULTRAFILTRATION MODE FOR SEVERAL MINUTES, THEY DEVELOPED CHEST PAINS AND OTHER DISCOMFORT WHICH RESULTED IN TERMINATION OF THE TREATMENT AND HOSPITALIZATION OF THE PTS. BLOOD SAMPLES REVEALED HIGH SODIUM LEVELS (150 MEQ AND 163 MEQ). PTS GIVEN FLUIDS ORALLY AND

UROLOGY~FII~FINAL~ONE OF SERVICE MEN AT DIALYSIS UNIT WAS ASKED TO

DIALYZED. [DESIGN PROBLEM

MlOO248lOl/O7/85lSACKS-VINE GASTROSTOMY KITIMICROVASIVEIMICROVASIVE INC131 MAPLE STIMILFORDIMA101757~SERIOUS INJURY1 190001GASTROENTEROLOGY- UROLOGY~KNT~FINAL~PT DEVELOPED ABDOMINAL PAIN AFTER CATHETER ASSEMBLY WAS PLACED. PT RETURNED TO SURGERY, BUMPER HAD DISLODGED FROM CATHETER AND PULLED OUT OF STOMACH. GASTRIC JUICES LEAKED INTO PERITONEAL CAVITY FROM HOLE WHERE CATHETER PULLED OUT. GASTROSTOMY WAS PLACED THROUGH SAME HOLE W/O PROBLEMS, NO TEARS IN STOMACH, NO FURTHER PROBLEMS. BASED ON EXTENSIVE TESTING OF DEVICE, MFG BELIEVES EXCESSIVE FORCE DURING PLACEMENT MAY HAVE CAUSED PROBLEM, OR PT MAY HAVE DISLODGED

Ml00252lOl/O7/85lPLAYTEX TAMPONlINTLPLAYlINTERNATIONAL PLAYTEX1215 COLLEGE RDIPARAMUSINJ107652)SERIOUS

IT. IQUERY/PRODUCT IMPROVEMENT

INJURY[ I ~OB/GYNIHEBIPRELIMINARY~ALLEGED TOXIC SHOCK SYNDROME. CAUSE UNKNOWN

MlOO285~Ol/O8/85~OMNI STANICOR GAMMAlCORDISlCORDIS CORPIP.0. BOX 025700~MIAMI~FL~33102~MALFUNCTION~334A~311-318~CARDIOVASCULAR~DXY~FINAL~A RATE DECREASE INDICATING APROACHING END-OF-LIFE WAS OBSERVED DURING ROUTINE MONTHLY MONITORING OF THE PT. THE PACER WAS REPLACED AFTER THREE YEARS OF IMPLANT WITH A NEW CORDIS PACER. CHANGE WAS ROUTINE AND UNEVENTFUL AND THE PATIENT'S CONDITION IS SATISFACTORY. CO CONFIRMED THE PACER, 334A-6936 HAD FAILED DUE TO EARLY BATTERY DEPLETION. NO PATIENT INJURY WAS INVOLVED IN, BUT THIS MALFUNCTION CAN BE EXPECTED TO RECUR IN OTHER PACERS. (SEE FILE) IMFG/FINISHING PROCESS

MlOO283~Ol/O8/85~AMIGO MOTORIZED WHEELCHAIRIAMIGSALEIAMIGO SALES16693 DIXIE HWYIBRIDGEPORTIMI148722lMALFlJNCTIONI I [PHYSICAL MEDICINE~INI~FINAL~AMIGO OWNER, FELL FROM HIS AMIGO WHILE OUTDOORS DESCENDING A STEEP RAMP. ALLEGES DYNAMIC BRAKING FAILURE, TORN PANTS AND

4

INJURY TO HIS ARM-FIVE STITCHES AT A MEDICAL FACILITY THE FOLLOWING DAY. GROSS MISUSE OF THE PRODUCT IS APPARENT.(USER

M100263101/07/851SIL SOFT (ELASTROFIL) IDOWCORNIDOW CORNING OPHTHALMIC14700 COLLEY AVEINORFOLKIVA123508 ISERIOUS

STERILE ULCER ON RT EYE DETECTED DURING EXAM (AT 4 O'CLOCK POSITION). VIROPTIC DROPS PRESCRIBED. EYE COMPLETELY HEALED AFTER 2 WEEKS. NEW LENS DISPENSED AND ARE BEING WORN SUCCESSFULLY. PRACTITIONER STATED REASON FOR REACTION WAS THE DEPOSIT BUILDUP OVER LENSES THAT CAUSED THE LENS TO STOP

IN JURY^ I ~OPHTHALMIC~LPM~FINAL~LENS DISPENSED 8/16/84. ON 10/10/84 SMALL

MOVING, THEREBY TRAPPING DEBRIS UNDER LENS. USER MlOO243~Ol/O4/85~OPTIMA MPTlTELECTRONICSlTELECTRONICS~lOl INVERNESS DR(ENGLEWOODICO(80112~DEATH152821 lCARDIOVASCULARlDXYlFINALlATTENDING MD THOUGHT THE PACEMAKER MAY HAVE CONTRIBUTED TO THE DEATH BY NOT PACING AT THE PROGRAMMED RATE. MFG HAS REQUESTED RETURN OF THE PACEMAKER FOR ANALYSIS BUT MD HAS REFUSED. MFG DISCLAIMER SUBMITTED.~MFG/MATERIALS

MlOO245lOl/O4/851BJORK SHILEY CONVEXO-CONCAVEISHILEYISHILEY, INC117600 GILETTE AVEIIRVINEICA1927141SERIOUS INJURY[ I ~CARDIOVASCULAR~LWQ~FINAL~STRUT FRACTURE, VALVE LEAFLET SEPARATES, VALVE INOPERABLE, DEVICE WAS EXPLANTED AND REPLACED. REQUESTED RETURN OF DEVICE. DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. PROBABLE CAUSE IS UNKNOWN. IMFG/PROCEDURE M100242 101/04/851PLAYTEX SUPER PLUS TAMPONlINTLPLAYlINTERNATIONAL PLAYTEX, INC1215 COLLEGE RDIPARAMUSINJ1076521SERIOUS INJURY[ I ~ O B / G Y N I H E B I P R E L I M I N A R Y ~ T O X I C SHOCK SYNDROME. CAUSE UNKNOWN MlOO160~Ol/O5/85~ENTRIFLEX TUBElBIOSMEDIPRODlBIOSEARCH MEDICAL PRODUCTSIP0 BOX 17001SOMERVILLEINJ~O8876~DEATHI 11472281GASTROENTEROLOGY-

PERFORATED THE LUNGS. TUBE WITHDRAWN AND PATIENT SATISFACTORY. LATER EXPIRED DUE TO OTHER CAUSE. PATIENT ALSO HAD ENDOTRACHEAL TUBE IN PLACE. LABELING INDICATES TO INSERT TUBE USING FLUOROSCOPE IN SUCH CONDITION. THIS WAS NOT DONE. IUSER

UROLOGY(FPD(FINALIPNEUMOTH0RAX OCCURRED ON TUBE PLACEMENT - TUBE

MlOOl80~Ol/O4/85~MAXI-MYST AEROSOL UNITIMEADJOHNIMEAD JOHNSON & COI2404 PENNSYLVANIA STREETlEVANSVILLElIN~4772l~SERIOUS INJURY1 (0585- 021ANESTHESIOLOGYICCQlFINALlTHIS IS THE FIRST EVENT REPORTED TO FIRM ASSOCIATED WITH THIS UNIT. A PHARMACY TECHNICIAN HAS REPORTED THAT A LAY CUSTOMER "WENT BLIND IN ONE EYE" AS A RESULT OF THE MACHINE'S MALFUNCTION (UNSPECIFIED). FURTHER DETAILS NOT AVAILABLE. A PHYSICIAN HAS RESPONDED THAT THIS PT DEVELOPED "RETINAL VEIN THROMBOSIS A FEW MINUTES AFTER INHALING NEBULIZED BRONCHODILATOR FROM AEROSOL UNIT."ITHIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE.

MlOO159~Ol/O4/85~BENNETT CASCADE IIlPURIBENNlPURITAN BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251SERIOUS INJURY[ I ~ANESTHESIOLOGY~BTT~FINAL~A CLINICAL INJURY? CASCADE 11 ATTACHED TO A 7200 VENTILATOR (S/N 8340866). CASCADE I1 SETTINGS: TEMP 32 DEGREES

5

CELSIUS, ALARM AT 35 DEGREES CELSIUS. ALARM DID OCCUR. CASCADE I1 HUMIDIFIER OVERHEATED AND ALARM WAS ACTIVATED. PT WAS THEN TRANSFERRED TO ANOTHER VENTILATOR. DR STATED THERE MAY HAVE BEEN SOME INJURY TO PT BUT NOT ANY PERMANENT INJURY. NO FURTHER OPINIONS HAVE BEEN OFFERED. MANUFACTURER DISCLAIMER SUBMITTED.lDESIGN PROBLEM

MlOOl58~Ol/O4/85~CLASSIC PLUS STRABISMUS SCISSORSlCODMSHURlCODMAN SHURTLEFF, INClUNKNOWNlRANDOLPH~MA~O2093 ISERIOUS INJURY1 136- 5000~OPHTHALMIC~HNF~PRELIMINARY~WHILE USING SCISSORS DURING REMOVAL OF RECURRENT CYSTIC SWELLING ON BACK, TIP BROKE. X-RAY WAS UTILIZED TO LOCATE THE TIP AND IT WAS REMOVED FROM PATIENT.lCAUSE UNKNOWN

MlOO223lOl/O8/85lVOLUME VENTILATORlPURIBENNlPURITAN BENNETT CORP112655 BEATRICE STREETILOS ANGELESICA1900661DEATHIMA2+21 lANESTHESIOLOGYlCBKlFINALlA QUADRIPLEGIC PT HAD DYSPNEA AND THEN DISCONNECTED HIMSELF. A LOW PRESSURE ALARM SOUNDED; MANOMETER READING: 0-5 CM H20. NURSE RESPONDED TO ALARM AND PATIENT TRANSFERRED TO ANOTHER VENTILATOR, PATIENT EXPIRED ON 1/7/85. ALTHOUGH THERE IS NO ALLEGATION THAT MACHINE CAUSED PT'S DEATH, CO FILED REPORT. VENTILATOR INSPECTION (AT HOSP WITH CO AND FDA REP) SHOWED THE PROXIMAL PRESSURE LINE FILTER OF THE PT CIRCUIT WAS BLOCKED. IT ALSO WAS INSTALLED IN AN INCORRECT LOCATION AND WAS INSTALLED BACKWARDS. THE RESULT WAS THE LOW PRESSURE ALARM WAS ACTIVATED, THERE WAS A LACK OF DEFLECTION ON THE SYSTEM PRESSURE GAUGE AND THE SENSITIVITY CONTROL OPERATED ERRATICALLY. THE VOLUMES DELIVERED WERE LOWER THAN SELECTED BY THE OPERATOR. THE HIGH PRESSURE LIMIT ALARMS WERE ACTIVATED AS THEY ARE INTENDED IN PROPER MACHINE OPERATION. UPON DETECTION OF A HIGH PRESSURE CONDITION, INSPIRATION WAS CANCELLED, AND, LOWER VOLUMES WERE DELIVERED. THE INCIDENT WAS CAUSED BY OPERATOR ERROR REGARDING THE INSSTALLATION AND CONDITION OF THE PROXIMAL PRESSURE LINE FILTER.lUSER

MlOO3Ol~Ol/O9/85~QUIET-AIR INSIGHTIMIDWESTIMIDWEST DIV OF SYBRON1901 W OAKTONIDES PLAINESIIL1600181SERIOUS INJURY1 17300141DENTALIEFBIFINALlDR ALLEGES HEARING LOSS OVER TIME (LAST TWO YEARS) BECAUSE OF USE OF THE DEVICE. DR OPERATED HAND PIECES AT 50-60 LBS PRESSURE; LABELING CAUTIONS AGAINST OPERATING DEVICES OVER 30 LBS. MFG DISCLAIMER SUBMITTED.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW- UP AND/OR OTHER ACTION IS INDICATED.

MlOOO20~Ol/O8/85~PEDIATRIC CONCHATHERM HEATERIRESPCAREIRESPIRATORY CARE INC1900 W UNIVERSITY DRIVEIARLINGTON HTSIIL1600041SERIOUS INJURY1 1380- IO~GENERAL HOSPITAL~FMT~FINAL~HEATER OVERHEATED. PATIENT BURNED. FIRM DOES NOT KNOW HOW SEVERELY. HOSPITAL HAS REFUSED TO PROVIDE FIRM WITH ANY INFORMATION AND HAS STATED THAT THEIR LEGAL DEPT WILL CONTACT FIRM. FIRM GOT REPORT THROUGH SALESPERSON WHO ORIGINALLY HEARD ABOUT INCIDENT ON 12/15/84, BUT FAILED TO NOTIFY HEADQUARTERS UNTIL 1/7/85. SALESPERSON NOTIFIED BY RESPIRATORY SUPERVISORITHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT

6

INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

MlOOO67~Ol/O8/85~JELCO/CATHILON~CRITIKON~CRITIKON INCIWEST QUEEN STREETlSOUTHINGTONlCT~O64891SERIOUS INJURY1 I [GENERAL HOSPITALlFOZlFINALllO INCIDENTS OF REDDENED AREA AROUND THE INSERTION SITE. INVESTIGATION TURNED OVER TO FIRM'S CONSULTANT ( A N EPIDEMIOLOGIST AT VANDERBILT UNIV SCHOOL OF MEDICINE). EXPECT ADDITIONAL INFORMATION 1/15/85. MAY BE DUE TO MEDICATION OR SKIN PREP PROCEDURE.lCAUSE UNKNOWN

M100100~01/09/85~016'~ STEERABLE GUIDEWIRElUNITSTATCATHINSTlUSCI DIVISION OF C R BARD1129 CONCORD RD~BILLERICIA~MA~0182l~MALFUNCTION~ 10089501CARDIOVASCULAR~DQXlFINAL~DURIN G REMOVAL, SPRING PORTION OF WIRE UNCOILED IN CORONARY ARTERY. IT WAS NOTED THAT WIRES DID NOT BREAK.lTHE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

MlOOl6l~Ol/O9/85~APPOSE SKIN STAPLERIDAVIGECKIDAVIS & GECK DIV OF AMER CYANAMID COlUNKNOWNlDANBURYlCT~O68lO~MALFUNCTION~ IFM 85-51GENERAL AND PLASTIC SURGERYlGDTlFINALlPHYSICIAN REPORTED PT'S SKIN WOUND HAD OPENED AS A RESULT OF THE STAPLE STRAIGHTENING OUT.~THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE CAUSE ASSOCIATED WITH THIS TYPE OF EVENT IS USUALLY ATTRIBUTED TO THE USE OF THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FURTHER FOLLOW-UP AND/OR ACTION IS INDICATED.

MlOOO66~Ol/O8/85~AMBULATORY INSULIN INFUSION PUMPICARDPACEICARDIAC PACEMAKERSIP. O. BOX 640791ST PAULIMN1551641SERIOUS INJURY191001 IGENERAL HOSPITALlFRNlFINALlTHE PT RECEIVED AN OVERDOSE OF INSULIN AND WAS HOSPITALIZED WITH SEVERE INSULIN REACTION. PHYSICIAN ALLEGES A PUMP MALFUNCTION.IOTHER

R100249~01/08/85~300 MA MOBILE X-RAY SYSTEMIPICKERIPICKER INTL1595 MINER ROADICLEVELANDlOH144143lSERIOUS INJURY1 1804 H~RADIOLOGICAL~IZL~FINAL~TECHNOLOGIST RCV'D ELECTRIC SHOCK FROM LINE CORD PLUG WHILE MANIPULATING PLUG END INTO WALL RECEPTACLE. TECHNOLOGIST HAS BEEN HOSPITALIZED FOR OBSERVATION. MFR BELIEVES THIS WAS A PRECAUTIONARY MEASURE. EKG TAKEN AFTER THE INCIDENT WAS NORMAL AND RELEASED.lCAUSE UNKNOWN

MlOO326lOl/lO/85lMA-2 VENTILATORlPURIBENNlPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONlMA- 21 lANESTHESIOLOGYlCBKlFINALlSERVICE CALL REVEALED THE FOLLOWING: BELLOWS POTENTIOMETER REQUIRED VOLTAGE ADJUSTMENT. OXYGEN PROBE REQUIRED CLEANING AND RECALIBRATION.ICAUSE UNKNOWN

MlOO325~Ol/lO/85(FOREGGER F-300 ANESTHESIA MACHINEIPURIBENN(PUR1TAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND

7

PARK/KS1662251MALFUNCTION1F-3001 (ANESTHESIOLOGYIBSZIFINALISERVICE CALL REVEALED THAT THE OXYGEN ANALYZER WAS SLUGGISH. REPLACEMENT BEING INSTALLED. ICAUSE UNKNOWN

MlOO324~Ol/l0/85~7200 VENTILATORlPURIBENNlPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 25905)OVERLAND PARKIKS166225)MALFUNCTION17200[ lANESTHESIOLOGYlCBKlFINALlSERVICE CALL REVEALED AN EXHALATION VALVE LEAK, WHICH WAS CORRECTED BY REPLACING A DEFECTIVE CASCADE JAR. AN ALARM LAMP WAS ALSO REPLACED.lCAUSE UNKNOWN

MlOO322~Ol/lO/85~FOREGGER F-300 ANESTHESIA MACHINEIPURIBENNIPURITAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS166225)MALFUNCTIONIF-3001 (ANESTHESIOLOGYIBSZIFINALISERVICE CALL REVEALED THAT THE NITROUS OXIDE YOKE WASHERS NEEDED REPLACING AND THE FLUOTHANE DIRECT READING VAPORIZER READ LOW AFTER 2%. MFR RECOMMENDED DISCONTINUED USE./CAUSE UNKNOWN

MlOO2OO~Ol/ll/85~FLO-GARD 6100 VOLUMETRIC INFUSION PUMPITRAVLABOITRAVENOL LABS INCll BAXTER PARKWAYlDEERFIELDlIL~60115~SERIOUS INJURY12M80401 /GENERAL HOSPITALIFRN(F1NALIPT SET VOLUME TO BE INFUSED AT 1,000 CC FOR OVERNIGHT INFUSION. AWAKENED IN MORNING-990CC INFUSED. BAG &

TUBING COMPLETELY EMPTY AT A LEVEL JUST PRIOR TO AIR-IN-LINE DETECTOR. BLOOD HAD BACKED UP IN HER BROVIAC CATHETER. DISCONNECTED, IRRIGATED AGAINST RESISTANCE AND DEVELOPED CHEST PAIN. SEEN IN AN EMERGENCY ROOM WHERE A CHEST X-RAY, LUNG SCAN, AND ARTERIAL BLOOD GASES WERE DONE. TESTS WERE NORMAL, PATIENT DISCHARGED. PUMP DID NOT MALFUNCTION, BUT IT WAS REPLACED TO ALLAY PT'S APPREHENSION. PT UNDERWENT REEDUCATION FROM CO. CIRCUMSTANCES RELATIVE TO THIS INCIDENT INDICATE IMPROPER USER TECHNIQUE MAY HAVE CAUSED OR SIGNIFICANTLY CONTRIBUTED TO THE INDICDENT. THE USER HAS BEEN INSTRUCTED IN THE PROPER USE OF THE DEVICE. NO FURTHER INFORMATION WILL BE FILED.lCAUSE UNKNOWN

MlOO323)Ol/lO/85~FOREGGER F-300 ANESTHESIA MACHINEIPUR1BENN)PURITAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS)662251MALFUNCTIONIF-3001 lANESTHESIOLOGYlBSZlFINAL1SERVICE CALL REVEALED LEAK AT THE DIRECT READING VAPORIZER MANIFOLD BAR. LEAK WAS REPAIRED. ICAUSE UNKNOWN MlOO32l~Ol/lO/85~FOREGGER F-300 ANESTHESIA MACHINElPURIBENNlPURITAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 25905)OVERLAND PARKIKS)662251MALFUNCTIONIF-3001 lANESTHESIOLOGYlBSZlFINALlSERVICE CALL REVEALED: 1) THE FLUOTHANE VAPORIZER READ LOW; MFR RECOMMENDED DISCONTINUED USE; 2) OXYGEN CONTROL VALVE DELIVERED 300 CC/MIN WHEN OFF, VALVE REPLACED; 3) FOREWARN BATTERIES NEEDED REPLACING; AND 4) OXYGEN AND NITROUS OXIDE CHECK VALVES WERE TIGHTENED.lCAUSE UNKNOWN

MlOO2lO~Ol/ll/85~PERICARDIAL 10.5 FR INTRAORTIC BALLOONlDATASCOPElDATASCOPE CORP13 FIR COURTlOAKLANDINJ107436lDEATHI 10684-00- 01471CARDIOVASCULARIDSP~FINALlBALLOON MEMBRANE WAS PENETRATED; BLOOD SEEN IN SAFETY CHAMBER. BALLOON PUMPING DISCONNECTED. PT DIED. PT HAD VASULAR DISEASE. PT WAS ON PUMPING TO WEAN FROM CPV.lOTHER

8

M100291101/11/85~STIMULATION TRANSMITTERIMEDTRONICIMEDTRONIC, INC16951 CENTRAL AVE NE, PO BOX 1250~MINNEAPOLIS~MN~5544O~SERIOUS INJURY135221 lNEUROLOGYlGZBlFINALIPT RECEIVED AN OVER STIMULATION EVENT WHEN SHE FAILED TO TURN OFF HER SPINAL CORD STIMULATOR WHILE CHANGING THE BATTERY, S INSTRUCTED- IN THE OPERATORS MANUAL. SHE STATED THAT SHE WAS HOSPITALIZED FOR A FEW DAYS FOR TREATMENT OF TEMPORARY BLADDER PARALYSIS. CO BELIEVES THE EVENT IS ATTRIBUTABLE TO OPERATOR (USER) ERROR.lUSER MlOO199~Ol/ll/85~IV SOLUTION ADMINISTRATION SET MINI DRIPITRAVLABOITRAVENOL LABS INCll BAXTER PARKWAYlDEERFIELDlIL~60015~SERIOUS INJURY12 COO021 [GENERAL HOSPITALlFPAlFINALlIV ADMIN SET DELIVERED A LARGER VOLUME OF FORMULA THAN DESIRED TO A LESS THAN 2 LB NEONATE. VOLUME CONTROLLED BY A CO INFUSION PUMP. APPROXIMATELY 100 CC OF FORMULA WAS DELIVERED VIA NASOGASTRIC TUBE IN APPROX ONE HOUR TO THE INFANT. NECESSITATED GASTRIC DECOMPRESSION. LABELING DOES NOT CONTAIN THIS INDICATION FOR USE. FOLLOWING THE GASTRIC LAVAGE THE NEONATE WAS REPORTED TO BE IN STABLE CONDITION. THE HOSPITAL ALSO INDICATED SEVERAL INCIDENTS OF MACRODROP FORMATION HAD OCCURRED DURING USE WITH THIS PRODUCE CODE. A TECHNICAL SUMMARY, "LARGE DROPS FORMED BY MINI-DRIP DEVICES", HAS BEEN PREPARED TO ADDRESS THE REPORTED MALFUNCTION. A PRODUCT INFORMATION LETTER WAS SENT TO ALL CONSIGNEES. FOLLOWING THIS CUSTOMER NOTIFICATION, A PRODUCT RECALL WAS EXECUTED. (SEE FILE) I DESIGN PROBLEM

M100310~01/10/85~MA 2+2 VENTILATORlPURIBENNlPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONlMA2+21 lANESTHESIOLOGYlCBKlFINAL[SERVICE CALL REVEALED THAT THE BELLOWS POTENTIOMETER WAS OUT OF ADJUSTMENT. READJUSTMENT RESTORED IT TO MEET SPECIFICATIONS.lTHIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED.

MlOO302~0l/lO/85~SA-2 SPIROMETER ALARMIPURIBENNIPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONlSA- 21 ~ANESTHESIOLOGY~BZK~FINAL~THE CIRCUIT BOARD AND BOOTS WERE REPLACED DURING A SERVICE CALL.lCAUSE UNKNOWN

MlOO266lOl/ll/85lAS6MP INFUSION PUMPIAUTOSYRIIAUTO-SYRINGEILONDONDERRY PIKEIHOOKSETTINH103104~DEATHI I [GENERAL HOSPITALlFRNlFINALlEIGHT-MONTH- PREGNANT FEMALE HAD BLOODSUGARS OVER 400. PHYSICIAN GAVE EXTRA INSULIN -

FETAL DEATH. PHYSICIAN FEELS PUMP IS NOT INVOLVED WITH DEATH, BUT WANTS IT CHECKED. MFG DISCLAIMER SUBMITTED.lCAUSE UNKNOWN

MlOO309~0l/lO/85~CASCADE I HUMIDIFIERlPURIBENNlPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONl I lANESTHESIOLOGYlBTTlFINALITHERM0-SWITCH WAS REPLACED DURING A SERVICE CALL.~THIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS.

9

BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED

MlOO308~0l/lO/85~CASCADE I HUMIDIFIERlPURIBENNlPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONl I lANESTHESIOLOGYlBTTlFINALITHERM0-SWITCH WAS REPLACED DURING A SERVICE CALL.lTHIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED.

MlOO307~Ol/lO/85~FOREGGER F-300 ANESTHESIA MACHINEIPURIBENN(PUR1TAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONIF-3001 lANESTHESIOLOGYlBSZlFINALlDURING SERVICE CALL, THE ETHRANE DIRECT READING VAPORIZER (DRV) WAS FOUND TO HAVE NO OUTPUT. [CAUSE UNKNOWN

M100306~01/10/85~MA 2+2 VENTILATORlPURIBENNlPUFtITAN-BENNETT CORP(9401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONlMA2+21 lANESTHESIOLOGYlCBKlFINAL[A 3-VOLUME CIRCUIT BOARD WAS REPLACED DURING A SERVICE CALL. THE UNIT GAVE A MAXIMUM VOLUME AT ANY VOLUME SETTING BEFORE THE BOARD WAS REPLACED.lCAUSE UNKNOWN

MlOO305~0l/lO/85~FOREGGER LIC ANESTHESIA MACHINEIPURIBENNIPURITAN-BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONl I lANESTHESIOLOGYlBSZlFINALlSERVICE CALL

CLEANING. THE NITROUS OXIDE YOKE WASHER WAS REPLACED.lCAUSE UNKNOWN REVEALED POWER TAKE-OFF CHECK VALVE NEEDED REPAIR AND ABSORBER NEEDED

MlOO265~Ol/ll/85~MICRO FINE INFUSION SETIAUTOSYRIIAUTO- SYRINGEILONDONDERRY PIKE~HOOKSETT~NH~03104~SERIOUS INJURY1 1ASIV-27- 107lGENERAL HOSPITALlFRNlPRELIMINARYlPT USING ASGMP INSULIN PUMP HAD HIGH BLOOD SUGARS - 400 TO 600 - PUMP FOUND LEAKING AT HUB. DR INTERVENED. HAD PT BOLUSED EVERY 2 HRS W/2-4 UNITS OF INSULIN TO CONTROL BLOOD SUGARS.IMFG/MISCELLANEOUS

MlOO304~Ol/lO/85~FOREGGER F-300 ANESTHESIA MACHINElPURIBENNlPURITAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONIF-3001 lANESTHESIOLOGYlBSZlFINALlSERVICE CALL REVEALED A LEAK IN A FREE-STANDING DIRECT READING VAPORIZER (DRV). THE LEAK WAS NOT COMPLETELY ELIMINATED; MFR SENT LETTER TO HOSP RECOMMENDING AGAINST FREE-STANDING DRV'S.lTHIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND/OR OTHER ACTION IS INDICATED.

Ml00257~01/11/85~SINGLE PT DELIVERY SYSTEMlDRAKWILLlDRAKE-WILLOCKll3520 SE PHEASANT CTIPORTLANDlOR197222lSERIOUS INJURY142161 IGASTROENTEROLOGY-

10

UROLOGYlFKPlFINALlPT SHOWED SIGNS OF SODIUM SICKNESS AFTER DIALYSIS (SODIUM-171 MEQ ONE HOUR AFTER). REPEATED WITH SAME RESULT. 15 HRS AFTER, SODIUM 166 MEQ. 24 HRS LATER, REDIALYZED; SODIUM DOWN TO 130-131 MEQ. NO MACHINE ALARM DURING 1ST DIALYSIS.(THIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE.

MlOO303~Ol/lO/85~FOREGGER F-100 ANESTHESIA MACHINEIPURIBENNIPURITAN- BENNETT CORP19401 INDIAN CREEK PKWY, PO BOX 259051OVERLAND PARKIKS1662251MALFUNCTIONIF-1001 lANESTHESIOLOGYlBSZlFINALlSERVICE CALL REVEALED LEAK IN A FREE-STANDING DIRECT READING VAPORIZER (DRV). MFR RECOMMENDS AGAINST USE OF A FREE-STANDING DRV. LEAK NOT COMPLETELY ELIMINATED. MFR SENT LETTER TO HOSP RECOMMENDING AGAINST FREE-STANDING DRV'S. ITHIS REPORT HAS NOT BEED INDIVIDUALLY EVALUATED AND HAS BEEN CLOSED USING A GROUP CLOSEOUT PROCESS. REPORTS OF EVENTS INVOLVING SIMILAR DEVICES WHICH HAVE BEEN EVALUATED HAVE NOT RESULTED IN ANY AGENCY ACTION AND HAVE BEEN CLOSED TO MONITORING STATUS. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOWUP AND(0R OTHER ACTION IS INDICATED.

V100255~01/11/85)GLUCOMETERREFLECTIVE PHOTOMETERIAMESIAMES-DIVISION MILES LABSIP0 BOX 401ELKHARTIIN1465151SERIOUS INJURY155801 ICLINICAL CHEMISTRYlCFRlFINALlCOMPLAINANT ALLEGED GLUCOMETER BLOOD GLUCOSE RESULTS WERE LOW & REPORTED DIFFICULTY OPERATING INSTRUMENT. COMPLAINANT IS THE MOTHER OF THE DIABETIC (HER DAUGHTER'S AGE NOT MENTIONED). ON THANKSGIVING MORNING, HER DAUGHTER TESTED HER BLOOD & OBTAINED A RESULT OF 145 MG/DL. THE MOTHER REPORTED THAT HER DAUGHTER ATE LITTLE THAT DAY, BUT DID NOT FEEL WELL, SO SHE RETESTED. THE RESULT WAS "LESS THAN 175 MG/DL" (EXACT RESULT NOT KNOWN.) THE NEXT MORNING THE MOTHER FOUND HER DAUGHTER IN A COMA. SHE REMAINED IN A COMA FOR 8 DAYS. THE HOSP BLOOD GLUCOSE TEST WAS GREATER THAN 4 0 0 MG/DL. THE DAUGHTER IS FINE NOW & BACK IN SCHOOL. ON 1/7/85, THE MOTHER CALLED THE CO CUSTOMER SERVICES DEPT BECAUSE SHE GOT AN "ERR" CODE. REVIEW REVEALED CONTROLS TRAIN ING WHEN THEY PURCHASED THE INSTRUMENT. UNIT RETURNED TO CO FOR EVALUATION. FIRM DISCOVERED COMPLAINANT WAS NOT USING CONTROLS. NO FORMAL TRAINING IN THE USE OF INSTRUMENT. THE READHEAD FILTER WAS DAMAGED DUE TO HUMIDITY. THE POWER SWITCH WAS INTERMITTENT AND THE BATTERY HOLDER WAS DAMAGED.IUSER

MlOOO76~Ol/lO/85~INFUSION CONTROLLERlIVAClIVAC CORP110300 CAMPUS POINT DRIVEISAN DIEGOICA1921211MALFUNCTION1260~ IGENERAL HOSPITAL~LDR~FINAL~HOSPITAL MIXES HYPERALIMENTATION AND INTRALIPIDS TOGETHER IN ONE 3000 CC BAG. THE MODEL 260 CONTROLLER WILL NOT DELIVER THIS MIXTURE ACCURATELY. IT INFUSES EITHER AHEAD OF, OR BEHIND SCHEDULE.[THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SEVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW- UP AND/OR OTHER ACTION IS INDICA

MlOOO75~Ol/lO/85~EQUIPMENT STAND DIEGO~CA~92121~MALFUNCTION~1060~

TED.

lIVAClIVAC CORP(10300 CAMPUS POINT DR GENERAL HOSPITAL~FOX~FINAL~EQUIPMENT I SAN

11

M765683101/03/97/ARTIFICIAL URINARY SPHINCTERIAMERMEDISYSTIAMERICAN MEDICAL SYSTEMS110700 BREN ROAD WESTIMINNETONKAIMN155343lSERIOUS I N J U R Y ~ 8 0 0 ~ N A ~ G A S T R O E N T E R O L O G Y - U R O L O G Y ( E L ~ T H E ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE. OTHER RELEVANT HISTORY, INCLUDES POST PROSTATECTOMY AND POST TUR; TURP; TURS IMPLANT DATE IS 12/27/95. EXPLANT DATE IS 2/5/96.1

M885671101/02/971VENTAK MINI+ IMPLANTABLE CARDIOVERTER

PAUL~MN~55112~MALFUNCTION~l74l~NA~CARDIOVASCULAR~LWS~FINAL~IMPLANTABLE CARIOVERTER DEFIBRILLATOR (ICD) HAS BEEN IDENTIFIED AS POSSIBLY CONTAINING RESIDUAL GASES (ARGON AND HELIUM) WHICH SHOULD HAVE BEEN REPLACED WITH NITROGEN DURING THE MANUFACTURING PROCESS. THIS COULD CAUSE ELECTRICAL STRESS DAMAGE DURING THE SERVICE CHARGING PROCESS. DR WAS NOTIFIED AND THE PT WAS BROUGHT IN FOR TESTING. THREE CAPACITOR REFORMS WERE PERFORMED, DEFIBRILLATION THRESHOLDS RE-TESTED, AND NORMAL DEVICE

DEFIBRILLATO~CARDPACE~CARDIAC PACEMAKERS, I N C . ~ ~ I O O HAMLINE AVE NIST.

WAS OPERATION WAS CONFIRMED. DR ELECTED TO LEAVE THE DEVICE IMPLANTED AT THIS TIME. THE DR WILL PERFORM MANUAL CAPACITOR REFORMS. THE NORMAL FOLLOW-UP SCHEDULE WILL BE FOLLOWED. THIS EVENT WAS REPORTED AFTER REVIEW OF RECORDS SHOWS THAT THE EVENT HAD NOT BEEN REPORTED EARLIER. THE DEVICE WAS TESTED AND OPERATES WITHIN SPEC AT THIS TIME.1

M885680/01/04/971REDY 20001GAMBHEALIGAMBRO HEALTHCARE11185 OAK ST.~LAKEWOOD~C0~80215~MALFUNCTION~REDY 20001604487-0061GASTROENTEROLOGY- UROLOGYIFKPIFINALIAT THE BEGINNING OF A DIALYSIS TREATMENT, THE FACILITY NOTICED THAT THE "TOTAL UF (ULTRAFILITRATION) WAS NOT READING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS ORIGINALLY REPORTED TO THE MFR ON 5/23/96, HOWEVER, THE MFR DETERMINED ALL RELATED COMPLAINTS TO BE MDR REPORTABLE AFTER THE NEW MDR REGULATIONS TOOK INTO EFFECT. THIS MDR WAS ALSO NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. DEVICE DISCARDED-UNABLE TO FOLLOW-UP. THE MEDICAL EQUIPMENT SERVICE TECH (MES) REPLACED THE LOAD CELL AND CALIBRATED TO MANUFACTURING SPECS. THERE WERE NO RELATED CPF DEFECTS REPORTED ON THIS MACHINE. THE AFFECTED LOAD CELL ASSEMBLY WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE THE MES DISCARDED IT UPON REPLACEMENT. WITHOUT THE AFFECTED COMPONENT AN EVALUATION AS TO THE FAILURE MODE COULD NOT BE DETERMINED. IF THE LOAD CELL WAS DEFECTIVE A LOAD CELL CIRCUIT ALARM WOULD BE GENERATED. THIS ALARM CONSISTS OF A STEADY AUDIBLE ALARM, THE TOTAL UF DISPLAY FLASHES, THE ULTRAFILTRATION CONTROL IS DISABLED, AND THE MACHINE ENTERS BY-PASS AS STATED IN THE DEVICE. IF THE MACHINE DOES NOT FIND A DEFECT IN THE LOAD CELL CIRCUIT THIS ALARM WILL NOT BE GENERATED. HOWEVER, ANY FLUCUATIONS IN THE LOAD CELL DURING A TREATMENT WILL BE NOTICED IN THE UF RATE. HOWEVER, ANY FLUCUATIONS IN THE LOAD CELL DURING A TREATMENT WILL BE NOTICED IN THE UF RATE. IF THE LOAD CELL STOPPED READING AT A CERTAIN POINT THE UF CIRCUIT WOULD TRY TO COMPENSATE AND THE UF RATE WOULD INCREASE. IF THE UF RATE DOES NOT STOP INCREASING THE MACHINE WOULD GENERATE A HIGH UF RATE ALRM. IN THIS INCIDENT, FOR AN UNKNOWN REASON, THE UF RATE STOPPED INCREASING, THERFORE THE ALARM DID NOT OCCUR. THE UF RATE ALARM ENTAILS A STEADY AUDIBLE ALARM AND THE MACHINE ENTERS THE BY-PASS MODE. AS STATED IN THE DEVICE. ( * ) I

1

M8856811 01/15/971COBE CENTRYSYSTEM 3 IGAMBHEALIGAMBRO HEALTHCARE11185 OAK ST.(LAKEWOOD~C0~80215~~LFUNCTION~NA~333lOO-OOl~GASTROENTEROLOGY- UROLOGY~FII~FINAL~DURING A DIALYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS ORIGINALLY REPORTED TO THE MFR ON 6/5/96. HOWEVER, THE MFR HAS DETERMINED THIS COMPLAINT TO BE MDR REPORTABLE AFTER THE NEW REGULATIONS TOOK INTO EFFECT. THIS MDR WAS ALSO INADVERTENTLY NOT REPORTED WITHIN THE ALLOTED TIME PERIOD. DEVICE FAILURE DIRECTLY CAUSED EVENT. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL, IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE REPORTED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR,BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL RECOMMENDS THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLED CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. ( X ) I

M885685101/06/971GUARDIAN~GUARPROD~GUARDIAN PRODUCTS14175 GUARDIAN ST.lSIM1 VALLEYICA1930631MALFUNCTIONI30756P130756PIPHYSICAL MEDICINElITJlFINALlUSER CLAIMS THAT WALKER LEG SNAPPED. FOUND AS A RESULT OF INTERNAL AUDIT OF COMPLAINT FILES. FAILURE MODE DETERMINED TO BE DUCTILE DUE TO IMPACT - NOT A FATIGUE FAILURE. WALKER WILL NOT SEE ANY IMPACT IN ANY NORMAL OR HEAVY USE. DETERMINATION IS THAT FAILURE OCCURED DUE TO ABNORMAL USE OR ABUSE. VERY POSSIBLE THAT USER LOST BALANCE AND FELL ON UNIT. STIFFENING INSERT IMPROVED IN ATTEMPT TO STRENGTHEN THIS AREA BEYOND ITS NORMAL INTENDED USE REQUIREMENT. TYPE OF REPORTABLE EVENT: BRUISE. I

M765746101/21/971SIDEKICK II(PRIDHEALCAREIPR1DE HEALTH CARE, INC.1182 SUSQUEHANNA AVEIEXETERIPA1186431SERIOUS INJURYISC2131SC2131PHYSICAL MEDICINElINIlFINALlENDUSER CLAIMS SHE FELL OFF SCOOTER TWO OR THREE TIME INJURING HER NECK. SHE IS NOW WEARING A BRACE. A REP WAS SENT TO THE PTS HOME TO EVALUATE THE DEVICE. THE REP TESTED THE DEVICE UNDER THE CONDITIONS INDICATED BY THE USER AND COULD NOT DUPLICATE THE EVENT. NO REMEDIAL ACTION WAS TAKEN.1

M765745101/21/971PRIDE GENTLE LIFT RECLINERlPRIDHEALCARElPRIDE HEALTH CARE, INC.1182 SUSQUEHANNA AVEIEXETERIPA1186431SERIOUS INJURY1 I IGENERAL HOSPITALlFSAlPRELIMINARYlFELL OUT OF LIFT CHAIR. FRACTURED LUMBER. THIS IS AN EVENT THE CHAIR HAS INVOLVED BUT ALL INDICATIONS ARE THAT THE CHAIR WAS NOT THE ROOT CAUSE OF THE EVENT. MANUFACTURE DATE: 6/15/94. I

2

M885753 101/31/971COBE CENTRYSYSTEM 3 IGAMBHEALIGAMBRO HEALTHCARE11185 OAK ST.~LAKEWOOD~C0~80215~MALFUNCTION~NA~333lOO-OOl~GASTROENTEROLOGY- UROLOGY~FII~FINAL~DURING A DIALYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL TREATMENT. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT DISCARDED UPON REMOVAL. HOWEVER, ON COMPLAINTS IT INDIACTES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CL;AMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER "NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOSSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. INFO INDICATES THAT THE LINE FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS./

M885746101/20/97(MONOLETTOR SAFETY LANCETlSHERDAVIGECKlSHERWOOD DAVIS AND GECK11915 OLIVE STREETIST. LOUIS~M0~63103~MALFUNCTION~NA~8881- 6020911GENERAL AND PLASTIC SURGERYIFMKIFINALINURSES SAY FIVE SAFETY LANCETS FAILED TO LOCK. NO INJURIES WERE REPORTED. RETURNED SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED. NO DEFECTS OF WORKMANSHIP WERE OBSERVED AND ALL TESTED DEVICES FIRED AND LOCKED IN PLACE. NO DEFECTS WERE OBSERVED. CO IS UNABLE TO PURSUE THE INVESTIGATION FURTHER DUE TO LACK OF INFO CONCERNING THE ACTUAL LOT AND THE ACTUAL SAMPLES WERE NOT RETURNED. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT NOT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY CO THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE ITS PRODUCT HAS MALFUNCTIONED.1

M885747101/21/971LEGENDlPRIDHEALCARElPRIDE HEALTH CARE, INC.1508 DELAWARE AVENUEIWEST PITTSTON~PA~18643~MALFUNCTION~SC300~ [PHYSICAL MEDICINE~INI~FINAL~SCOOTER TOOK OFF ON ITS OWN. COULD ONLY BE STOPPED BY REMOVING KEY. AFTER INSERTING KEY, SCOOTER ACTION WAS ERRATIC. SOMETIMES FORWARD, REVERSE, OR NOT AT ALL, SOMETIMES WHEN ACTIVATED, OTHER TIMES WITHOUT BEING ACTIVATED. FINALLY RETURNED TO DEALER, AND RETURNED TO FACTORY. A BAD SITUATION FOR A HANDICAPPED PERSON. MALFUNCTION WAS CAUSED BY MOTOR CTONTROLLER PC BOARD. THIS IS NOT A COMMON MALFUNCTION WITH THESE TYPE OF CONTROLLERS BUT A SMALL PERCENTAGE WILL FAIL LIKE THIS. CO WILL MONITOR THIS TYPE OF FAILURE AND TAKE CORRECTIVE ACTION IF NECESSARY. THE DISTRBUTOR REPLACED THE CONTROLLER AND RETURNED THE DEVICE TO THE USER. FEMALE PT IS 60 YRS OLD. DOB: 4/4/36, WEIGHT 200 LBS. (DEN: 1009352) . I

3

M885748101/21/971LEGENDlPRIDHEALCARElPRIDE HEALTH CARE, INC.1508 DELAWARE AVENUEIWEST PITTSTONIPA1186431MALFUNCTION~SC300~ [PHYSICAL MEDICINElINIlFINALlEND USER HAS DEVICE EQUIPPED WITH A LEFT HAND PUSH/PULL THROTTLE CONTROL. IT USES A STEEL ROD AS AN ACTIVATOR. THIS ROD MUST BE LIGHT WEIGHT TO FUNCTION CORRECTLY. IF THE THROTTLE IS PUSHED TOO HAD IT CAN SLIP BENEATH THE HAND GRIP AND BECOME WEDGED. THE THROTTLE IS SET TO BE AT MAXIMUM BEFORE THE ROD TOUCHES THE HAND GRIP. PUSHING IT TOO HAND GRIP WILL NOT PROVIDE ANYMORE SPEED TO THE VEHICLE. FEMALE PT IS 5 0 YRS OLD. DOB: 4/11/46. WEIGHT 230 LBS. (DEN: 1009561).1

M885750101/14/971METZENBAUM SCISSORSlSNOWPENClSNOWDEN PENCER15175 SOUTH ROYAL ATLANTA DR.~TUCKER~GA~30084~MALFUNCTION~89-5100~89- 51001GASTROENTEROLOGY-UROLOGY~KNS~FINAL1DEVICE ALLEGEDLY CAUTERIZED ADD'L PT AREAS BEYOND WHAT WAS INTENDED DURING A LAPAROSCOPIC PROCEDURE.1

M885763 102/03/971COBE CENTRYSYSTEM 31GAMBHEALIGAMBRO HEALTHCARE11185 OAK ST.(LAKEWOOD~C0~80215~MALFUNCTION~NA~333lOO-OOl~GASTROENTEROLOGY- UROLOGYlFIIlFINALlDURING A DIALUYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. CLAMP DEVICE FAILURE DIRECTLY CAUSED EVENT. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. ON OTHER COMPLAINTS IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OF INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECCOMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. TGHE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS.[

M885764102/03/971COBE CENTRYSYSTEM 31GAMBHEAIIGAMBRO HEALTHCARE11185 OAK ST.~LAKEWOOD~C0~80215~MALFUNCTIONINA)333lOO-OOl~GASTROENTEROLOGY- UROLOGY~FII~FINAL~DURING A DIALUYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. CLAMP DEVICE FAILURE DIRECTLY CAUSED EVENT. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL. ON SOME OTHER COMPLAINTS IT INDICATES THAT

4

THE TABS ON WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OF INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL, VERSION 1995/10, RECCOMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE CO'S CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATION, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS.1

M885623101/31/971ALLERGAN CUPIALLEOPTIIALLERGAN OPTICAL18301 MARS D R I V E ~ W A C O ~ T X ~ 7 6 7 1 2 ~ ~ L F U N C T I O N ~ N I ~ N I ~ O P H T ~ L M I C ~ L Y L ~ F I N A L ~ A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT REOCCURRENCE OF THIS EVENT. ACTUAL SITE OF MANUFACTURE OF COMPLAINT PRODUCT COULD NOT BE DETERMINED.1

M885629101/31/971ALLERGAN CUPIALLEOPTIIALLERGAN OPTICAL18301 MARS DRIVE~WACO~TX~76712)MALFUNCTION~NI~NI~OPHTHALMIC~LYL~FINAL~A CUP BURST DURING USE. NO INJURY OCCURRED. A RETAINED UNIT OF THE SAME LOT WAS TESTED AND PASSED FOR ALL SHELF-LIFE SPECS. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF THIS EVENT. ACTUAL SITE OF MANUFACTURE OF COMPLAINT PRODUCT COULD NOT BE DETERMINED. I

M885757101/31/971ALLERGAN CUPIALLEOPTIIALLERGAN OPTICAL18301 MARS D R I V E ~ W A C O ~ T X ~ 7 6 7 1 2 ~ ~ L F U N C T I O N ~ N I ~ N I ~ O P H T ~ M I C ~ L Y L ~ F I N A L ~ A CUP BURST DURING USE. NO INJURY OCCURRED. THE MFR IS IMPLEMENTING CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF THIS EVENT. ACTUAL SITE OF MANUFACTURE OF COMPLAINT PRODUCT COULD NOT BE DETERMINED.\

M765772102/03/971PER-Q-CATH 3.0-FR P31BARDACCESYSTIBARD ACCESS SYSTEMS15425 WEST AMELIA EARHART DR.lSALT LAKE CITY(UT1841161SERIOUS INJURY~4133000(41330OO~CARDIOVASCULAR~DQO~FINAL~THE CATHETER WAS PLACED 2/17/95 FOR THE TREATMENT OF MASTOIDITIS. IT WAS REPORTED THAT WHEN THE PT WAS RELEASED FROM THE HOSP ON 2/18/95 THERE WAS LEAKAGE AT THE CATHETER EXIT SITE. THE PT DEVELOPED SEPSIS AND THE CATHETER WAS REMOVED 3/13/95. IMPLANT DATE: 2/17/95. EXPLANT DATE: 3/13/95. THE CATHETER WAS CLEANED AND EXAMINED MICROSCOPICALLY. THERE WAS SLIGHT OVER STRETCH DAMAGE TO THE CATHETER TUBING IMMEDIATELY DISTAL TO THE HUB. THIS TYPE OF DAMAGE IS USUALLY CAUSED BY MANIPULATION OF THE CATHETER HUB DURING DRESSING CHANGES. OVER STRETCH DAMAGE WEAKENS THE CATHETER TUBING, WHICH COULD RESULT IN EVENTUAL BREAKAGE OF THE CATHETER. THIS TYPE OF DAMAGE CAN BE AVOIDED BY SECURING THE CATHETER BY FOLLOWING THE MFR'S

5

INSTRUCTIONS FOR USE. THE CATHETER WAS LEAK TESTED TO 80PSI AND NO LEAKS WERE FOUND. EXAM OF THE CATHETER FOUND NO OTHER PRODUCT DEFECT. I

M765773102/05/971KAZ INC.IKAZIKAZ, INC.14411 ROUTE 91HUDSONINY1125941SERIOUS INJURY~llSI~NA~ANESTHESIOLOGY~KFZ~FINAL~PT WAS AT A TABLE WITH HIS HEAD DOWN TO THE STEAM, HE WENT TO MOVE AND THE HOT WATER SPILLED OUT OF THE SIDE OF THE UNIT. IT LEFT A LIGHT SCAR WHERE HE WAS BURNED. INHALER HAS NOT BEEN RETURNED.[

M765778102/14/971ACCUFIXlTELEPACISYSTlTELECTRONICS PACING SYSTEMS,

801~0330801~CARDIOVASCULAR~DTB~FINAL~LEAD CAPPED DUE TO LOSS OF SENSING AND LOSS OF CAPTURE. THE J RETENTION WIRE REMAINS IMPLANTED. IMPLANTED: 10/8/92. EXPLANTED: 10/27/92. DEVICE MANUFACTURE DATE: 9/3/92.ITHE CAUSE OF THIS PROBLEM HAS NOT BEEN DETERMINED. THIS IS A RECOGNIZED ADVERSE AFFECT ASSOCIATED WITH THE DEVICE OR ITS USE AS STATED IN LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. BOTH THE FREQUENCY AND THE SEVERITY

INC. 17400 S. TUCSON WAY~ENGLEWOOD~CO~80112~SERIOUS INJURY1330-

OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW- UP AND/OR OTHER ACTION IS INDICATED.

M765785101/27/971VENTAK PRX AUTOMATIC IMPLANTABLE CARDIVERTER

PAULIMN1551121SERIOUS INJURY117051NAICARDIOVASCULAR~MKJIFINALIA PT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A DEFIBRILLATION LEAD EXPERIENCED OVERSENSING/INAPPRORIATE THERAPY. AN INVASIVE PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO REPLACE THE COMPLETE SYSTEM. IMPLANTED: 7/12/94, EXPLANTED APPROXIMATELY: 2/12/96 (IMPLANTED 19 MONTHS. A FDA 5 DAY SERIOUS INJURY REPORT WAS ALSO SUBMITTED ON THE

DEFIB~CARDPACE~CARDIAC PACEMAKERS, INC.~~IOO HAMLINE AVE NIST.

DEFIBRILLATIONLEAD. THIS RPEORT IS BEING RE-SUBMITTED BECAUSE THE ICD AND LEAD HAVE BEEN RETURNED TO CPI FOR ANLAYSIS. WHEN THE ICD WAS RECEIVED AT CO, IT WAS IN "MONITOR ONLY" MODE, INDICATING THAT THE ICD COULD MONITOR AND DETECT ARRHYTHIMAS, BUT THERAPY DELIVERY HAD BEEN PROGRAMMED OFF. IT WAS FURTHER REPORTED TO CO THAT HOSP STAFF HAD PROGRAMMED ICD TO STOP DELIVERING THERAPY TO PREVENT FURTHER INAPPROPRIATE SHOCKS TO PT. CO'S ANALYSIS FOUND THAT ICD MET SPECS AND OPERATED NORMALLY THROUGH ALL TESTING. (NO DESTRUCTIVE ANALYSIS WAS NECESSARY; ALL TESTS WERE PERFORMED WITHOUT REMOVING ICD CASE). BASED ON TEST RESULTS OF ICD, CO CONCLUDED THAT ICD WAS NOT RELATED TO INAPPROPRIATE SHOCKS REPORTED. TEST RESULTS FOR LEAD WILL BE REPORTED ON MDR REPORT WHEN ANALYSIS IS COMPLETED.1

M885799~01/31/97~ACCUFIX~TELEPACISYST~TELECTRONICS PACING SYSTEMS,

701~0329701~CARDIOVASCULAR~DTB~FINAL~FAILURE ANALYSIS PROVIDED. AMLE PT. DOB: 2/2/34. IMPLANTED: 12/27/88. EXPLANTED: 7/5/89. MANUFACTURE DATE: 11/29/89. THIS ENTIRE FORM FILLED OUT BY MFR. COMPONENT/SUBASSEMBLY FAILURE: WIRE STIFFENER. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. 10/20/94 LEAD PULLED FROM STORAGE FOR INVESTIGATION OF

INC.17400 S . TUCSON WAY~ENGLEWOOD~CO~80112~MALFUNCTION~329-

POSSIBLE "J" STIFFENER WIRE FRACTURE. VISUAL INSPECTION AND X-RAY OF LEAD DISTALLY INDICATES "J" STIFFENER WIRE FRACTURE APPROX 20" PROXIMAL OF DISTAL WELD SITE.[

M885783102/24/971BIPOLAR ENDOCARDIAL TINED LEAD BTlOlCARDPACElCARDIAC PACEMAKERS, INC.14100 HAMLINE AVE NIST. P A U L ~ ~ ~ 5 5 1 1 2 ~ ~ L F U N C T I O N / 0 0 1 0 1 N A ~ C A R D I O V A S C U L A R ~ D T B ~ F I N A L ~ I ~ L ~ ~ L E CARDIOVERTER DEFIBRILLATOR (ICD) BEGAN BEEPING AND HAD REACHED ELECTIVE

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REPLACEMENT TIME. WHEN INTERROGATING THE ICD, THE LAST (ICD), THE LAST SHOCK IMPEDANCE INDICATED THAT LAST SHOCK WAS DELIVERED TO AN ELECTRICALLY OPEN LEAD, AND THE PT REPORTED RECEIVING ASYMTOMATIC SHOCKS. THE ICD WAS REPLACED AND RETURNED TO CO FOR ANALYSIS. FURTHER INVESTIGATION WILL BE DONE REGARDING THE REPORTED OPEN LEAD IMPEDANCE AND INAPPROPRIATE SHOCKS. IMPLANT DATE: 6 / 2 / 9 2 EXPLANT DATE: 7 / 1 7 / 9 6 IMPLANT TIME: 4 9 MONTHS. FURTHER INVESTIGATION COULD NOT CONFIRM A LEAD PROBLEM. THE ICD WAS RETURNED TO CO FOR ANALYSIS. THE ICD OPERATED NORMALLY IN TESTING AND EXHIBITED NORMAL BATTERY DEPLETION. THE LEAD WAS NOT RETURNED FOR ANALYSIS, AND NO FURTHER INFO ABOUT A LEAD PROBLEM WAS FOUND.[THE CAUSE OF THIS PROBLEM HAS NOT BEEN DETERMINED. THIS IS A RECOGNIZED ADVERSE AFFECT ASSOCIATED WITH THE DEVICE OR ITS USE AS STATED IN LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. BOTH THE FREQUENCY AND THE SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.

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CONCLUSIONES:

En este trabajo de investigación se realizó la búsqueda de información concerniente a los problemas que se presentan con equipo médico, esta información se encontró de manera muy precisa en la Agencia Norteamericana llamada FOOD AND DRUG ADMINISTRATION que gracias al programa MEDWATCH la información obtenida es basta, en las siguientes hojas de este trabajo se anexa parte de la información que se analizó para conjuntar y determinar las preguntas que se realizan en el programa, mismas que son la parte medular del presente trabajo.

Al mencionar que solo se expone parte de la información en este trabajo, me refiero a que la mayoría se encuentra en disquetes, siendo un total de 100 MB (megabytes) de información con la que se cuenta para el análisis. Para la realización del cuestionario en el programa, se consultó solo parte del total de información es decir, solo se consultó los casos de los años 1985,1986, 1996 y 1997, analizando un total de 400 casos, los casos analizados fueron escogidos al azar del total de cada año.

Finalmente la parte central del programa se encuentra en el software desarrollado, y las anteriores cuartillas son una breve explicación del uso del programa los fundamentos y motivos del porque del proyecto.

En tiempo futuro se seguirá trabajando en el código del programa para que éste pueda crecer, junto con la experiencia que se valla adquiriendo y recopilando de los ingenieros Biomédicos de los distintos hospitales con los que tenga trato.

Quien deseé obtener copia del programa ejecutable para apoyo en la toma de decisiones o para aportar sus experiencias, agradeceré que le soliciten una copia del mismo, al coordinador de la licenciatura en Ingeniería Biomédica del Plantel Iztapalapa.

RICARDO SANTIAGO GÓMEZ

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