Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn patients and health care providers to carefully monitor their Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.
The FDA recently received medical device reports (MDRs) associated with issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines.
This safety communication provides:
- Important information about reported problems with DreamStation 2 CPAP machines.
- Recommendations for people who use the machines, their caregivers, and health care providers.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with Philips DreamStation 2 CPAP machine to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education.