FDA issues warning for DreamStation 2 Based on currently available evidence, agency does not believe safety issue is related to foam
By HME News Staff
Updated 8:59 AM CST, Wed November 29, 2023
AMSTERDAM – The U.S. Food and Drug Administration yesterday issued a safety communication to inform users of possible thermal issues with the Philips Respironics DreamStation 2 CPAP machine and to advise them to monitor the machines for signs of overheating.
The FDA recently received medical device reports (MDRs) associated with issues like fire, smoke, burns and other signs of overheating while using the machine. The agency is in ongoing discussions with Philips about mitigation strategies and will provide updates accordingly.
“The FDA is committed to assuring this new safety issue is resolved expeditiously,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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. 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 says between August 1, 2023, and November 15, 2023, it received more than 270 reports of problems associated with the machine, compared with fewer than 30 MDRs received in the previous three years.
Philips says the reports, while filed over the last three months, cover a three-year period following a retrospective review of possible complaints related to the DreamStation 2 since its launch.
“Philips Respironics conducted review and analysis regarding reports of the possible thermal issues in accordance with its regulatory processes,” the company said in a statement. “The devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.”
In October, the FDA requested that Philips conduct additional testing on the health risks related to the sound abatement foam in certain recalled Philips ventilators and BiPAP and CPAP devices.
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