Dive Brief:

• The Food and Drug Administration has received more medical device reports (MDRs) linked to Philips’ respiratory products that include reports of death, according to updated data shared by the agency on Wednesday. 
• From the start of July to the end of September last year, the agency received more than 7,000 MDRs that contained 111 reports of death. The FDA says it can't determine whether devices cause events reported in MDRs based on report submissions alone.
• The additional reports increased the total number of MDRs and death reports received by the FDA since April 2021 to 116,000 and 561, respectively. 

Dive Insight:

The FDA published the update days after Philips revealed it has entered into a consent decree with the agency. As part of the decree, Philips has agreed to stop selling new sleep therapy devices or other respiratory care products in the U.S.

The FDA began providing periodic updates on the number of MDRs and deaths linked to Philips’ ventilators and sleep apnea devices after the company began recalling millions of products in 2021. The number of reports increased after the recall began. Philips submitted 30 MDRs in the decade up to April 2021. In May, June and July 2022, the FDA received more than 48,000 MDRs about the devices. 

While the rate of MDR submissions has slowed since the initial surge, the FDA continues to receive thousands of reports a month, on average. The rate of submissions from July to September 2023 was the highest since late 2022. The reports cover injuries such as cancer, pneumonia, asthma, infection, headache and cough. 

The uptick in MDRs was accompanied by an increase in reports of deaths. The FDA received 44 reports in the first quarter of 2023, 32 reports in the second quarter and 111 reports in the third quarter, the most recent data published by the agency. 

FDA officials also increased the number of reports of deaths in the historical reporting periods in light of Philips’ retrospective review of MDRs. The latest round of revisions, which follows an earlier update in June 2023, added 33 reports of death to the original figures.