The US Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.

The FDA says in a safety communication that it recently received 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. 

The agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between Aug 1 and Nov 15, 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.

This new safety issue comes as the FDA continues to monitor Philips’ handling of the June 2021 recall impacting millions of sleep therapy and respirator machines, including CPAP machines. The polyester-based polyurethane (PE-PUR) foam used in the recalled machines to reduce sound and vibration can break down and could potentially be breathed in or swallowed, posing possible risks to the person using the device.

Of note, the DreamStation 2 machines are manufactured with a silicone-based foam, not PE-PUR foam, and were not included in the June 2021 recall. However, consumers should be aware that some of these machines were distributed as replacement machines for some users whose machines were affected by the June 2021 recall. 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. 

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 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,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a 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.”

The FDA issued the following 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.

At this time, if you are not experiencing these issues, then the FDA does not recommend discontinuing use of these machines. Concerns about the CPAP machine, including unusual smells, sounds, or changes in appearance, can be reported to the FDA and Philips.

The FDA says in the safety communication that it is working with the company 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, according to the safety communication, which notes that the FDA is also in ongoing discussions with the company about mitigation strategies for this safety issue.

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