Dive Brief:

• Another 40 people may have died after using Philips ventilators, BiPAP machines or CPAP machines included in a recall involving millions of the devices, the Food and Drug Administration said Friday.
• New medical device reports received by regulators bring the total number of deaths associated with the Philips devices to 385 since the recall was announced in June 2021.
• The FDA said it is not changing recommendations from the June 2021 safety communication for use of the recalled devices.

Dive Insight:

Philips is replacing or repairing more than five million sleep apnea devices and ventilators recalled due to the breakdown of polyester-based polyurethane foam used to soundproof the machines.

In its latest update on the situation, the FDA said it received more than 6,000 medical device reports associated with the recalled ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines between Jan. 1 and March 31.

The agency, in its prior update in February, disclosed an additional 82 deaths from 8,000 reports tied to the Philips devices in the last two months of 2022.

The new data brings the total number of medical device reports linked to the Philips machines to more than 105,000 since April 2021, the FDA said.

Mario Fante, a Philips spokesman, said the data released by the FDA was previously disclosed and published by the company on April 24. 

“The vast majority (~94%) of the approximately 105,000 MDRs filed since April 2021 up to and including March 2023 are alleged technical malfunctions that do not involve serious injury,” Fante wrote in an email.  

He noted that the submission of a report to the FDA is “not evidence” that the device caused or contributed to the the outcome, a position also taken by the FDA. Still, the FDA has labeled the recall “Class I,” which the regulator says “involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

Philips last month released results of a third-party risk assessment of its recalled sleep apnea machines that said potential patient exposure to foam particles or volatile organic compounds from the devices “is unlikely to result” in an appreciable harm to health in patients.

Attorneys representing patients suing Philips over the recalled devices called the results of the company’s report “PR spin masquerading as research.”

Philips has said it will lay off about 10,000 workers by 2025 as it moves to cut costs, streamline operations and improve its performance.

Updates with comment from Philips.