FDA issues warning about DreamStation 2 CPAP machines

Philips Respironics reports 270 incidents of 'thermal issues'

NBC Universal, Inc.

The Food and Drug Administration issued a new warning for users of certain CPAP machines – the latest in a series of troubles for Philips Respironics, one of the leading manufacturers of the breathing devices that help people with sleep apnea.

The FDA issued the alert for users of the Philips DreamStation 2, citing an increase in reports the device can overheat, causing smoke, fire and burns.

In June 2021, the company issued a recall for millions of its breathing devices over concerns the foam used in those machines could be toxic, break down and be inhaled by users. According to the FDA, the DreamStation 2 uses a different foam and was sent as a replacement device after that recall.

Between August and Nov. 15, Philips reported to the FDA more than 270 incidents of "thermal issues" with the DreamStation 2.

While the situation is developing, the problem may be related to an "electrical" or "mechanical malfunction" that has caused some of the machines to overheat, the FDA said.

In a statement, Philips said its "number one priority is patient safety and quality" and the devices can "continue to be used provided that the safety instructions ... are followed."

The FDA advises users to inspect and examine their machines for unusual smells or changes in appearance before and after each use, noting some of the issues may only arise when the machine is running. Be careful to pay attention before falling asleep, and unplug the machine if there are any unusual smells or sounds coming from the device.

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