FDA Warns on Safety Issue With Philips CPAP Devices
November 28 2023 - 4:25PM
Dow Jones News
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.
The regulator said that it continues to monitor the company's
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 16:10 ET (21:10 GMT)
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