FDA warns of Philips CPAP machines overheating, causing patient injuries

Key takeaways:

• Reports of fire, smoke, burns and other signs of overheating are emerging for DreamStation 2 CPAP machines by Philips Respironics.
• Users should watch for unusual smells or changes in the machine’s appearance.

The FDA has issued a safety communication regarding reports of fire, smoke, burns and other signs of overheating in DreamStation 2 CPAP machines by Philips Respironics, according to a press release.

“The FDA is committed to assuring this new safety issue is resolved expeditiously. We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.”

Patient injuries were cited in some of the more than 270 reports about DreamStation 2 thermal problems submitted to the FDA between Aug. 1 and Nov. 15. In a statement, Philips said it filed the reports, which cover a 3-year period, following a review of possible thermal complaints.

The company said it is “in discussions with the [FDA] regarding the reports.”

The safety communication from the FDA advises users to follow manufacturer instructions for operating and cleaning the CPAP machine, as well as inspect the machine for unusual smells or changes in appearance before, during and after each use.

Users should unplug the machine if they smell burning or unusual odors, the machine’s appearance or performance changes, if water is spilled on it or if it is making unusual sounds.

The FDA said reports so far indicate the issue could be related to an electrical or mechanical malfunction causing the machine to overheat. The agency does not believe it is tied to foam used in the machine, which was behind a 2021 recall of Philips machines.

References:

• Carefully monitor Philips DreamStation 2 CPAP machines for signs of overheating: FDA safety communication. https://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication. Published Nov. 28, 2023. Accessed Nov. 30, 2023.
• Philips statement on recent FDA safety notification related to DreamStation 2. https://www.philips.com/a-w/about/news/archive/standard/news/press/2023/20231129-philips-statement-on-recent-fda-safety-notification-related-to-dreamstation-2.html. Published Nov. 29, 2023. Accessed Nov. 30, 2023.