(WKBN) - The U.S. Food and Drug Administration issued a safety alert on Tuesday about an "emerging safety issue" with some CPAP machines.
According to the FDA, the Philips Respironics’ DreamStation 2 CPAP machine was having thermal issues that caused patient injuries. CPAP (Continuous Positive Airway Pressure) machines are used for the treatment of obstructive sleep apnea.
The FDA recently received medical device reports (MDRs) associated with issues such as fire, smoke, burns, and other signs of overheating while using the machine.
Reports gathered and analyzed by the FDA indicate the thermal issues may be related to an electrical and/or a mechanical malfunction that may cause the machines to overheat in certain situations. However, the FDA does not believe the safety issue is related to the foam used in the machine.
The FDA first became aware of this issue during a routine analysis of MDRs. The agency noted a sharp increase in the number of MDRs (more than 270 reports) associated with thermal issues between Aug. 1, 2023, to Nov. 15, 2023.
The FDA recommends that anyone using the machines follow the instructions in the user manual and check the machine for unusual smells or changes in appearance before and after each use.
"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 Dr. Jeff Shuren, 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."
The FDA is in discussions with the company about mitigation strategies for this safety issue and will update the public accordingly.
