Nellcor Puritan Bennett 980 Ventilator System

1ETM627 Rebecca King – Nellcor Puritan Bennett 980 Ventilator System

Nov 30 2014

Product Recall

ETM627 Rebecca King – Nellcor Puritan Bennett 980 Ventilator System Nov 30 2014

2

What: Puritan Bennett™ 980 Ventilator

Recall Date: October 1, 2014[5]

Why: The ventilator system has a software issue that may stop the ventilator completely. The software problem causes the ventilator to stop working after the air and oxygen supply lines are disconnected, often for a tank change or maintenance, and then reconnected. This can lead to severe breathing issues, and even death in some cases.

Incidents: While no deaths have been reported due to the faulty 980 Ventilator System, there have been scattered reports to the company regarding the problem. This ventilator is primarily used in hospitals, where back-up ventilators are available for these types of emergencies. As of July, Covidien had received a total of 4 reports from hospitals regarding ventilators malfunctioning.

Number of Units Sold: 324 units

When Sold: January 3, 2014 through August 22, 2014

Management Issues

3

Recognition of Problem: The ventilators with the software issue that affects the system were operating with the 2.8 software version that was distributed in March of 2014. Hundreds of these ventilators were distributed to individuals and hospitals, who primarily use them for premature babies and elderly patients who struggle to breath on their own. Covidien now has a total of five Class I recalls since 2012, making it one of the highest companies for Class I recalls than any in the world.

Speed of Response: Covidien’s response to this recall has been swift and efficient. The company quickly compiled a list of devices that could be affected by the software issue and released those serial numbers to the public. They have also been working on a software update to for their ventilators across the board to prevent this problem from happening again.

Responsibility: Covidien has been very responsive and compliant in regards to this recall. They have taken full responsibility and are working to correct the issue quickly, especially given that this device could hold a patient’s life in its hands.

ETM627 Rebecca King – Nellcor Puritan Bennett 980 Ventilator System Nov 30 2014

Impact of Recall

ETM627 Rebecca King – Nellcor Puritan Bennett 980 Ventilator System Nov 30 2014

4

Legal Consequences: Covidien can be held legally responsible for any deaths or injuries resulting from the 9890 Ventilator failure. The FDA has issued a Class I recall for all affected devices, as it could potentially cause injury or death due to the ventilator stopping. Since this is not the first potentially life threatening problem with Covidien medical devices, the FDA is thoroughly investigating their quality protocols to determine if further legal action should be taken.

Reputation: Covidien has been under harsh scrutiny for several years now due to five other Class I recalls that could potentially result in a patient’s death. This incident seems to have only solidified public distaste with the company, as they continue to release products with software defects. The company is preparing to merge with Medtronic, a company who has also suffered severe criticism for the high quantity of defective medical devices they have released. This incident seems to just be the icing on the cake for Covidien, so to speak.

Sales: Since Covidien is able to release a new software update to fix the ventilator issue, their sales have not been affected. The company’s sales numbers may drop slightly after their merger with Medtronic due to the number of issues that Medtronic has encountered with their medical devices, but currently Covidien sales have not been affected.

References

ETM627 Rebecca King – Nellcor Puritan Bennett 980 Ventilator System Nov 30 2014

5

[1] Reyes, Angel. “Puritan Bennett 980 Ventilator Recalled – Reyes Law Blog.” Reyes Browne Reilley Personal Injury Attorneys, Dallas, TX. N.p., n.d. Web. 30 Nov. 2014.

[2] “Software Issues Result in Class I Recall of Nellcor Puritan Bennett, 980 Ventilator System.” NewsInferno. N.p., 13 Nov. 2014. Web. 30 Nov. 2014. <http://www.newinferno.com/software-issues-result-in-class-i-recall-of-nellcor-puritan-bennett-980-ventilator-system/>.

[3] “U.S. Food and Drug Administration.” Nellcor Puritan Bennett, 980 Ventilator System. Np., 7 Nov. 2014. Web. 30 Nov. 2014. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm422326.htm.

[4] Newmarker, Chris. “How Covidiean Has a Serious Ventilator Software Problem | Qmed.” How Covidien Has a Serious Ventilator Software Problem | Qmed. N.p., n.d. Web. 30 Nov. 2014. http://www.qmed.com/news/how-covidien-has-serious-ventilator-software-problem.

[5] “Anesthesiology News – Class 1 Recall of Puritan Bennett 980 Ventilator Systems for Bad Software.” Anesthesiology News – Class 1 Recall of Puritan Bennett 980 Ventilator Systems for Bad Software. N.p., 10 Nov. 2014. Web. 30 Nov. 2014. http://www.anesthesiologynews.com/ViewArticle.aspx?d=Web%2BExclusives&d_id=175&i=November+2014&i_id=1119&a_id=28780.

[6] “Class 1 Device Recall Puritan Bennett.” Class 1 Device Recall Puritan Bennett. N.p., 26 Nov 2014 Web. 30 Nov. 2014. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130226.

[7] “Nellcor Puritan Bennett, 980 Ventilator System Recalled (ClassI): AttorneyOne Monitors and Keeps Consumers Informed” PRWeb. N.p., 11 Nov. 2014. Web. 30 Nov. 2014. http://www.prweb.com/releases/2014/11/prweb12319610.htm.