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FDA Updates CPAP Deaths and Medical Device Reports

The FDA recently released an update on the number of medical device reports (MDRs) linked to recalled Philips CPAP, BiPAP, and ventilator machines. These MDRs reflect the complications experienced by users, shedding light on the alarming number of complaints tied to Philips devices. In its latest development, the FDA notified the public of 105,000 medical device reports relating to issues caused by the toxic particles inside sleep apnea devices. Out of the tens of thousands of MDRs, there were 385 CPAP deaths.

FDA Announces More CPAP Deaths and Complications

In 2021, Philips recalled millions of devices patients used to treat their sleep apnea. The sound abatement foam, intended to reduce the noise of the machines, could disintegrate, releasing cancer-causing particles and gases. If inhaled or ingested by patients, these contaminants could lead to cancer, organ damage, respiratory problems, and more.

Following the massive recall, the FDA has continued to track CPAP deaths and injuries through its medical device reporting system. Prior to this latest June notification, the FDA announced in February that it had received 98,000 MDRs. Of these 98,000 MDRs, the FDA counted 346 CPAP deaths. On June 2, 2023, the FDA posted a new safety communication, relaying more than 6,000 medical device reports. These MDRs included 40 CPAP deaths from January 1, 2023, to March 31, 2023. This data brings the total number of recorded MDRs to 105,000, with a total of 385 CPAP deaths. Although this is a decline from the 8,000 MDRs received between November 1, 2022, and December 31, 2022, it is nonetheless a concerning reminder about the persistent problems with these recalled devices.

Philips CPAP Lawsuits Continue to Climb

In response to the defect in Philips sleep apnea machines, individuals have filed lawsuits against the company. Patients accuse Philips of knowing about the problem with the foam in the machines well before the recall in 2021, leaving users unaware of the potentially cancerous particles in their devices for years.

In June 2023, the number of cases pending in the Philips CPAP multidistrict litigation reached 548. Attorneys expect a further increase in these cases as patients can develop health problems months after breathing in the toxic debris.

The Lake Law Firm Is Helping Those Injured by Philips Sleep Apnea Devices

If you or a loved one have been affected by the recalled Philips sleep apnea devices and have suffered injuries or complications, you may be entitled to file a claim. The Lake Law Firm is actively working to hold Philips accountable for their negligence and to help victims obtain the compensation they deserve. Contact us today at (888) 525-3529 for a free consultation to see if you qualify for a Philips CPAP lawsuit.