82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346

Dive Brief:

Another 82 deaths linked to Philips’ recalled sleep and respiratory devices were reported to the Food and Drug Administration in the final two months of last year.
In total, the agency has now received 346 reports of death. The rate of death reports per month has risen in each reporting period since Philips began the recall in the summer of 2021.
The deaths were among the more than 8,000 medical device reports (MDRs) sent to the FDA in November and December. The regulator has received more than 98,000 MDRs about the recalled devices.

Dive Insight:

The numbers associated with the Philips recall of ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines have risen throughout the regulatory process. Philips sent 30 MDRs associated with the breakdown of PE-PUR foam to the FDA in the decade up to April 2021. Over the following year, the company submitted more than 21,000 MDRs.

While the rate of new MDRs has tailed off since peaking from May to July 2022, the death rate keeps rising. After adjusting its figures in light of Philips’ retrospective review of the reports, the FDA lists 123 deaths in the first year of its dataset, 45 for May to July and 96 for August to October. The agency initially put the August to October figure at 91, but it now has raised it in response to Philips’ review of the MDRs.

As it stands, the FDA has yet to adjust the figures for November and December in response to Philips’ MDR review but, with the earlier updates changing the number by five deaths, at most, the months are poised to have the highest death rate in the dataset. The number of deaths per month rose from 15 to 32 to 41 across the three latest reporting periods.

Late last year, Philips presented the results of studies of its recalled DreamStation CPAP machines that found exposure to degraded foam is unlikely to harm patients. Asked about the MDRs and death reports at the time, Philips’ Chief Medical Officer Jan Kimpen said the company “could not connect any of the complaints to the use of these devices.”