Philips statement on recent FDA safety notification related to DreamStation 2
- Nov 29, 2023
- 1 minute read
Philips Respironics’ number one priority is patient safety and quality. Philips Respironics is in discussions with the U.S. Food and Drug Administration (FDA) regarding the reports it filed with the FDA related to possible thermal issues in the humidifier of the DreamStation 2 sleep therapy device while in use.
Philips Respironics filed these approximately 270 reports over the last three months which cover a three-year period following a retrospective review of possible thermal complaints related to DreamStation 2 since the launch of the product.
The FDA has issued a safety communication on this matter: Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication | FDA.
Philips Respironics conducted a review and analysis regarding reports of the possible thermal issues in accordance with its regulatory processes. The devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.
