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.
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