Recent medical device reports regarding Philips’ CPAP machines have registered additional fatalities, expanding the number of deaths that were observed in report complaints, according to the U.S. FDA.
According to an updated tally published by the FDA this month, as of the end of 2022, the agency has received more than 98,000 medical device reports (MDRs) in response to the recall. The count stretches back to April 2021, when Philips first publicized the issues with many of its CPAP and BiPAP machines and other devices that would ultimately spark the official recall in June 2021.
The most recent additions to the tally include more than 8,000 MDRs received between Nov. 1 and Dec. 31. Those complaints include 82 reported deaths; in total, 346 deaths have now been reported in response to the recall.
Both the FDA and Philips noted that MDRs represent an unaudited pool of complaints that haven’t been confirmed to be directly linked to the recall at hand.
Read the full article at Fierce Biotech.