FDA Updates Medical Device Report Numbers for Philips Respironics Recall

The FDA has updated the number of medical device reports (MDR) reportedly associated with the June 2021 recall of Philips Respironics ventilators, bilevel positive airway pressure, (BiPAP) and continuous positive airway pressure (CPAP) machines, to 98,000, including 346 deaths.

The update reflects mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients received from Nov. 1, 2022, to Dec. 31, 2022, potentially associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the devices.

The FDA says it will conduct an in-depth review of the new MDRs, including possible reasons for the increased number of reports.

The MDRs reflect a wide range of injuries, including respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.