“We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. 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.
“The FDA is committed to assuring this new safety issue is resolved expeditiously. The FDA is in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly. 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 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.
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.
