FDA Issues Update on Medical Device Reports Involving Philips CPAP Machines
The FDA has announced an update on the number of medical device reports it has received related to recalled Philips Respironics ventilators, BiPAP machines, and CPAP machines. The federal safety regulator has been posting regular updates containing information it receives on these reports. In its latest safety communication dated June 2, 2023, the FDA notes that between January 1, 2023 and March 31, 2023, it received over 6,000 medical device reports related to recalled Philips sleep apnea machines, with 40 new reports of death.
Millions of sleep apnea devices manufactured by Philips that were equipped with a potentially dangerous type of sound abatement foam were recalled two years ago in June 2021. This foam, known as PE-PUR foam, helps to reduce the noise made by the machine to allow users and their partners to get a better night’s sleep. However, this type of foam may degrade and break down over time, releasing potentially life-threatening carcinogenic toxins into the user’s airways.
Philips CPAP and BiPAP users have filed lawsuits against the company, claiming that Philips knew of the health risks the PE-PUR foam presented, but did not warn consumers. Individuals that used a Philips PAP model or mechanical ventilator between 2009-2021 may be eligible to file a lawsuit against the manufacturer. Health problems that have been associated with these devices include various cancers such as cancer of the liver, lungs, kidneys, and throat.
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