FDA Warns of Thermal Problems with Philips DreamStation 2 CPAPs

The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding Philips’ DreamStation 2 continuous positive airway pressure (CPAP) machines, adding to the ongoing troubles in its Respironics division.
 
Though unrelated to the major respiratory recall in 2021, the FDA has received medical device reports of thermal issues like fire, smoke, burns and other signs of overheating when using DreamStation 2 CPAP machines. The agency also said the issues might be related to an electrical and/or mechanical manlfunction that can cause it to overheat in certain situations.

The FDA stated it “first became aware of this issue during a routine analysis of the MDRs that were submitted to the FDA. The agency noted a sharp increase (more than 270 reports) in the number of MDRs associated with thermal issues of the machine between Aug. 1, 2023, to Nov. 15, 2023. Prior to Aug. 1, 2023, the agency had received fewer than 30 MDRs associated with thermal issues with the device since it was cleared for marketing on July 10, 2020.”
 
The DreamStation 2 CPAPs were distributed as replacements for recalled DreamStation 1 CPAPs. The FDA said it doesn’t believe the safety issue with DreamStation 2 is related to the foam used in the machine, stating that DreamStation 2 machines are manufactured with a silicone-based foam.
 
Philips said in a response statement that the reports were filed after a retrospective review of potential thermal complaints regarding DreamStation 2 since the product’s launch.
  
The FDA advised users to unplug and don’t use the CPAP machines if they smell burning, smoke, or any unusual odors; hear unusual sounds; the machine changes appearance; there are unexpected changes to performance; or water is spilled into the machine.
 
The machines can still be used if safety instructions in its IFU are followed, including letting the heater plate and water tank cool for about 15 minutes before removing it.