By Ben Glickman

 

The U.S. Food and Drug Administration warned of an emerging safety issue involving a continuous positive airway pressure, or CPAP, machine made by Philips.

The FDA issued a safety communication about thermal issues with the Philips Respironics' DreamStation 2 CPAP machines, which are used to treat forms of sleep apnea, and recommended patients monitor machines.

The agency said it had received reports of issues such as fire, smoke, burns and other signs of overheating. The FDA said it is in discussions with the company about strategies to address the safety issue.

The FDA said that it noted a "sharp increase" in the number of medical device reports related to the machines between Aug. 1 and Nov. 15.

Philips said in a statement that its priority is patient safety and quality, and that it filed reports with the FDA following a three-year retrospective review of complaints linked to the product.

The company said the devices can still be used if the safety instructions for the product are followed.

The FDA said that it continues to monitor the Philips' handling of a June 2021 recall involving sleep therapy and respirator machines, which was related to a foam used in certain products.

The FDA said it does not believe the safety issue is related to the foam used in the DreamStation 2.

 

Write to Ben Glickman at ben.glickman@wsj.com

 

(END) Dow Jones Newswires

November 28, 2023 18:24 ET (23:24 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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