FDA Cautions Public of Safety Issue with Philips' DreamStation 2 CPAP Machines

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Nov 28, 2023, 15:25 ET

SILVER SPRING, Md., Nov. 28, 2023 /PRNewswire/ -- Today, as part of the U.S. Food and Drug Administration's continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics' DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treatment of obstructive sleep apnea.

The FDA issued a safety communication to inform the public of reports involving thermal issues with the machine, some of which cited patient injuries, and to provide safety recommendations for patient use, including carefully monitoring machines for signs of overheating.

The agency recently received medical device reports (MDRs) associated with issues, such as fire, smoke, burns and other signs of overheating while using the machine. The FDA is in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly.

"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," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "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."

While the FDA continues to analyze and address this issue, the agency is recommending those who use the machine to follow the manufacturer's instructions in the user manual and to inspect and examine the machine for unusual smells or changes in appearances before and after each use. More information on the agency's safety recommendations can be found in the FDA's safety communication on this issue.

The FDA uses mandatory reporting of MDRs from device manufacturers, device user facilities, and importers to help detect postmarket device-related safety issues. The agency reviews all MDRs and closely monitors these reports, alongside other information sources, to identify a possible safety signal for further review and evaluation, and takes action, as appropriate.

More specifically, the agency first became aware of this issue during a routine analysis of the MDRs that were submitted to the FDA. The agency noted a sharp increase (more than 270 reports) in the number of MDRs associated with thermal issues of the machine between Aug. 1, 2023, to Nov. 15, 2023. Prior to Aug. 1, 2023, the agency had received fewer than 30 MDRs associated with thermal issues with the device since it was cleared for marketing on July 10, 2020. The FDA continues to closely monitor reports of adverse events related to this issue and will update the public as we become aware of any new, significant safety information.

This new safety issue comes as the FDA continues to closely 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. This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate the thermal issues may be related to an electrical and/or a mechanical malfunction of the machine, which may cause it to overheat in certain situations. The FDA is working with the company to better understand the issue(s) related to the machine and the possible underlying cause(s) and will update the public with new information, as appropriate.

The FDA will continue to take steps to ensure patients and providers have the most reliable and up-to-date information regarding this new safety issue, as well as safety issues pertaining to Philips' recalled medical devices.

Additional Resources:

Media Contact: Carly (Kempler) Pflaum, 240-672-8872
Consumer Inquiries: Email, 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration