(Washington, D.C) – The U.S. Food and Drug Administration 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.
