Respironics Reports 111 Deaths in 3Q 2023: FDA

Two days after Philips Respironics announced a consent decree (see story) where it would stop marketing its troubled ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, FDA is now announcing updated medical device reports and reports of death associated with the devices.

According to the update, FDA has received over 7,000 medical device reports (MDRs) and 111 death reports from 7/2/2023 to 9/30/2023 that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in Philips Respironics’ ventilators, BiPAP machines, and CPAP machines included in a recall announced 6/2021. “Since April 2021, the FDA has received more than 116,000 MDRs, including 561 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown,” the update says.