FDA Received Over 116,000 MDRs for Philips Respirators, BiPAPs, CPAPs

Establishing the magnitude of the Philips Respironics recall, the FDA has announced that since April 2021, the agency has received more than 116,000 medical device reports (MDR), including 561 reports of deaths, associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the company’s ventilators, BiPAP machines, and CPAP machines.

The MDRs include both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients, the FDA said. A wide range of injuries have been reported among the 116,000 MDRs, including cancer, pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.

According to the FDA, between 2011 and April 2021, Philips submitted 30 MDRs that the company identified as associated with the PE-PUR foam breakdown. Eight of those reports were from the U.S. and none of the included reports of patient injury or death. The agency added that in April 2021, Philips first notified the FDA of their intention to conduct a field action and the company formally submitted their Report of Correction and Removal in June 2021.

Read the FDA’s updated Philips MDR data here.

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