The US Food and Drug Administration (FDA) updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.
The update indicates there have been over 6,000 medical device reports and 40 new deaths during that period.
Manufacturers, such as Philips, are required to submit medical device reports when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer 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.
Philips submitted 30 medical device reports between 2011 and April 2021 that they identified as associated with the PE-PUR foam degradation. Eight of those reports were from the US. There were no reports of patient injury or death among those 30 medical device reports.
In April 2021, Philips first notified the FDA of its intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. The company formally submitted its Report of Correction and Removal in June 2021.
Since April 2021, the FDA has received more than 105,000 medical device reports, including 385 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
In April this year, Philips issued a recall of certain reworked DreamStations that were also recalled in June 2021.
