FDA warns of overheating issues with Philips brand CPAP machines
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.
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.