The US FDA is warning patients and healthcare providers to carefully monitor Philips DreamStation 2 CPAP machines for signs of overheating, according to an agency alert sent November 28.

According to the alert, the FDA recently received a “sharp increase” in medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines.

Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years, the agency said.

“Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine. This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate that the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations,” the FDA said in the alert.

The agency says it is working with Philips to better understand the issue(s) related to the DreamStation 2 CPAP machine and the possible underlying cause(s) and will update the public with new information, as appropriate. 

“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 a press 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.”


FDA Recommendations

  • Follow the manufacturer’s instructions in the user manual, including:
    • place the CPAP machine on a firm, flat surface
    • keep the CPAP away from carpet, fabric, or other flammable materials
    • carefully clean the CPAP machine
    • empty the CPAP machine’s water reservoir
    • let the CPAP machine’s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan.
  • Inspect and examine the CPAP machine before and after each use for unusual smells or changes in its appearance. Some problems may only be noticeable when the machine is running, so pay attention to any differences in the CPAP machine as you prepare for bed, before you fall asleep.
  • Unplug the CPAP machine and do not use it if:
    • you smell burning, smoke, or any unusual odors,
    • there is a change in the appearance of the CPAP machine,
    • there are unexplained changes to the CPAP machine’s performance,
    • water is spilled into the CPAP machine,
    • you hear unusual sounds coming from the CPAP machine.

If you are unable to use your CPAP device due to these issues, discuss your individual health situation with a health care provider, such as your primary care physician or sleep doctor.