In the three month period from May 1, 2022, through July 31, 2022, the US Food and Drug Administration (FDA) received more than 48,000 medical device reports (MDRs), including 44 reports of death, associated with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown or suspected foam breakdown implicated in the Philips Respironics’ CPAP recall. This is in addition to the more than 21,000 MDRs, including 124 reports of death, that were submitted in April 2022 and the 30 MDRs (with no reports of death) received before the CPAP recall was announced.
Manufacturers, such as Philips, are required to submit medical device reports when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.
Submission of a medical device report itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. In an earlier statement, Philips Respironics states that it investigates all allegations of device malfunction, death, or serious injury.
The FDA’s in-depth review and analysis of these new medical device reports will include examining the possible reasons for the increased number of reports during this time. The MDRs included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in the medical device reports, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain.