Philips Respironics Adverse Medical Event Reports Reach 100,000

According to a news report published on newsbreak.com, Philips Respironics has recently released an update concerning its ongoing recall of millions of CPAP and BiPAP ventilators and other respiratory devices designed for sleep apnea. These breathing machines were recalled after it was discovered that the sound abatement foam could degrade, releasing carcinogenic, toxic fumes and particles into the user’s airway.

The United States Food and Drug Administration has reported that there have been 260 deaths connected to the sound abatement foam issue. Along with the company’s recall update, Philips admitted that it depended on a limited toxicological risk assessment. Philips stated in April 2021 that the company received “a steep increase in complaints allegedly associated with possible foam degradation,” and this led to its recall of millions of breathing machines.

Now more than a year later, Philips stated that it had acquired a clearer understanding of the potential health risks. The company’s CEO, Roy Jakobs, stated, “I would like to stress that we are very sorry that it has taken this much time, but the testing involved long throughput times and needed to be done thoroughly. We deeply regret the concern and uncertainty felt by patients, their physicians, and customers, and we continue to work hard to address their needs.” Jakobs also announced the new chief patient safety and quality officer, Steve C de Baca. Mr. de Baca brings over 30 years of regulatory affairs and quality improvement experience to the company.

According to Philips, there have been about 20,500 medical device reports (MDRs) filed with the FDA. These medical device reports occurred between April 2021 through April 2022. Another 79,000 medical device reports have been filed since the last report bringing the total to more than 99,000 medical device reports filed since April 2021.

Philips stated that as many as 93% of the medical device reports don’t involve serious injury. Philips investigates all reports of technical malfunction, injury, or death. Philips Respironics states that it has not found any conclusive data that connects the recalled devices with the deaths reported in some of the MDRs.

Get Legal Help From Our Philips Breathing Machine Lawyers Today

To find out if you or your loved one can file a Philips Respironics Ventilator, CPAP, or BiPAP lawsuit, call Parker Waichman LLP for a free legal consultation. Call 800-968-7529 or use our online chat feature to speak with our attorneys, who will help you understand your rights and work hard to obtain the compensation you or your loved one deserves.