FDA receives additional reports of casualties linked to Philips’ recalled respiratory devices

The Food and Drug Administration (FDA) has observed a surge in medical device reports (MDRs) concerning Philips’ respiratory products, including instances of fatalities, according to recent data released. Between July and September last year, the FDA received over 7,000 MDRs, with 111 reporting deaths.

While the FDA notes it cannot definitively establish causality between the devices and reported events based solely on these submissions, these reports have contributed to a total of 116,000 MDRs and 561 death reports since April 2021. 

The update follows Philips' consent decree with the FDA, under which it has agreed to cease selling new sleep therapy devices and other respiratory care products in the U.S. The FDA began issuing periodic updates after Philips' large-scale product recalls in 2021, with submission rates peaking from May to July 2022. Despite a decline since then, the FDA still receives thousands of reports monthly. 

The rise in MDRs correlates with an increase in death reports, with 111 recorded in the third quarter of 2023 alone. Additionally, FDA officials have adjusted historical death report figures following Philips' retrospective review of MDRs, adding 33 reports in the latest revision.