91 more deaths were reported due to the Phillips respirator recall, total death toll reaches 260

91 more deaths were reported due to the Phillips respirator recall, the total death toll reaches 260 between April 2021 and November 2022, and Phillips received over 90,000 complaints regarding its sleep apnea devices and ventilators.

Nearly a year and a half ago, Phillips began recalling its respiratory devices after receiving complaints about how the polyester-based polyurethane foam used for soundproofing the vibrations of its devices was breaking down over time causing chemicals and debris to float into the airways. 

The potential health risks of the disintegrating PE-PUR foam used for muffling sound include headache, difficulty breathing, dizziness, chest pain, cancer, pneumonia, asthma, infection, and more.

Approximately 5.5 million of the company’s CPAP and BiPAP machines and other affected devices have been called back in a recall that began in June 2021. Despite this, the FDA has still been receiving complaints.

Between 2011 and April 2021, Phillips passed on only 30 medical device reports (MDRs) to the FDA in a bid to detect potential device-related safety issues. Of these, nine were related to death or injuries resulting from the respiratory recall. 19 months later, over 90,000 complaints have piled up of which more than half or 48,000 complaints, were received between May 1 and July 31 of this year.  21,00 MDRs were received between Aug. 1 and Oct. 31. These complaints were filed by healthcare providers, consumers, and patients.

While most of the complaints received at this point were of non-fatal injuries, 91 complaints reported patient death. Adding this number to the existing number of complaints that link the faulty ventilators to potential fatalities, the death toll has now been raised to 260. Over 120 of these complaints were submitted between April 2021 and April 2022, and the remaining patient death reports came in between May 1 and July 31.

Despite the large numbers of MDRs submitted in the wake of the class 1 ventilator recall, the FDA has clarified that not all death reports and injuries can be linked to it.

“The incidence, prevalence or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about details such as frequency of device use,” the agency stated.

Presently, the agency is putting its efforts towards determining why reports are continuing to increase, given that the latest wave of patient death reports is more than double the size of the previous one.

This can possibly be attributed to Philips’ inadequate notification efforts. The rate at which the company is notifying users of affected devices and is beginning to repair and replace them is considered to be too slow by the FDA.
The FDA and the U.S. Department of Justice are both making efforts to mitigate these concerns. While FDA has proposed another order on Phillips’s replacement and repair program the DOJ is in talks about a consent decree with the device maker. In the most extreme circumstances, it is also possible that production at certain manufacturing sites will be shut down till all recall-related issues are resolved.