According to a safety communication last updated in June 2023, the FDA had received more than 105,000 medical device reports, including 385 deaths linked to degraded PE-PUR foam. The reports, received between April 2021 and March 31, 2023, include cancer, pneumonia, dizziness, asthma, headache, infection, cough, difficulty breathing and chest pain.
Philips attributed some foam degradation to the use of CPAP cleaning machines using ozone. Manufacturer SoClean Inc. sued Philips and filed an amended complaint referencing the FDA’s report in December 2021. The complaint claims Philips knew the foam could cause “serious risk of harm” for years, but instead of warning the public, it focused blame on SoClean.
Lawsuit Documents Show Philips Knew About CPAP Risks
In June 2022, unsealed court documents revealed that Philips knew about problems with its foam for at least three years before the recall. Philips claimed off-gassing chemicals from its PE-PUR foam wouldn’t cause health problems unless exposed to ozone cleaners, which made the foam 14 times more likely to degrade.
“The FDA’s investigation further reveals the company’s own internal testing showed the degradation products of PE-PUR foam are toxic and potentially carcinogenic. The company chose to keep using the PE-PUR foam anyway and did not alert the public to the risk of harm.”
Brendan McDonoughATTORNEY WITH WEITZ & LUXENBERG
The FDA issued another recall — a Class I Recall — for the reprogrammed replacement devices because of safety issues with the settings. The FDA also released a statement in April 2023 addressing the number of replacement Philips CPAP devices from the most recent replacement recall. The FDA stated that the
number of replacement devices sent to customers was far below the almost 2.5 million Philips had claimed.
https://www.drugwatch.com/philips-c...d Philips,pressure, cough and sinus infection.