Latest FDA Update Details Deaths, Injuries Associated with CPAP Machines
Since the recall last summer, millions of patients using certain Philips CPAP, BiPAP, or mechanical ventilators to assist with breathing have had a hard decision to make: continue using the defective machines or face their own health risks (namely, sleep apnea) by not using them.
The issue with the devices (and reason for the recall) has to do with the specific type of foam the machines were made with to quiet the vibrating noises when running. This foam, known as PE-PUR foam, is a polyester-based material. Over time, the material breaks down, causing tiny particles and gasses to be released into the machines. Some of these particles and gasses have been found to be toxic, and contain carcinogens. If breathed in over a period of time, device users may develop certain cancers, kidney or liver failure, or acute respiratory distress syndrome, among other dangerous health conditions.
In its latest update, the FDA indicates that since April 2021, the safety regulator has received more than 69,000 medical device reports (MDRs) related to this problem. MDRs are required to be submitted to the FDA by manufacturers when information reasonably suggests that the device may have caused injury or death, or if the device has malfunctioned to the degree that if it were to malfunction again, it may cause injury or death. These reports include 168 reports of death related to PE-PUR foam breakdown or suspected foam breakdown. Out of these 168 reports of death, 44 of them were received by the FDA in just three short months (May 1, 2022 and July 31, 2022).
Plaintiffs across the country have filed lawsuits against Philips, claiming the company knew of the health risks associated with the PE-PUR foam outfitted in certain CPAP, Bi-PAP and mechanical ventilator models, but did not warn consumers.
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Our experienced attorneys are investigating Philips CPAP and BiPAP lawsuit claims. If you have used one of these devices and have since suffered from side effects, it is important to contact a lawyer immediately. Contact us by submitting the form or by calling us at (888) 984-7988 for a confidential consultation. It’s not too late to investigate your potential claim.