Dreamstation 2 Safety Communication
Summary: Continue using device unless experiencing issues listed below. Follow manufacturer instructions and precautions also listed.
Health System Services will continue to monitor the situation and await further guidance from the FDA and Philips Respironics. Continue to check our website.
At this time, replacement devices are not available from Philips.
FDA Safety Communication re. Philips Dreamstation 2:
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
Date Issued: November 28, 2023
The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.
The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines. The agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years.
Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine. This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate that the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.
Recommendations for Patients, Caregivers, and Health Care Providers
- Follow the manufacturer’s instructions in the user manualExternal Link Disclaimer, including:
- place the CPAP machine on a firm, flat surface
- keep the CPAP away from carpet, fabric, or other flammable materials
- carefully clean the CPAP machine
- empty the CPAP machine’s water reservoir
- let the CPAP machine’s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan.
- Inspect and examine the CPAP machine before and after each use for unusual smells or changes in its appearance. Some problems may only be noticeable when the machine is running, so pay attention to any differences in the CPAP machine as you prepare for bed, before you fall asleep.
- Unplug the CPAP machine and do not use it if:
- you smell burning, smoke, or any unusual odors,
- there is a change in the appearance of the CPAP machine,
- there are unexplained changes to the CPAP machine’s performance,
- water is spilled into the CPAP machine,
- you hear unusual sounds coming from the CPAP machine.
If you are unable to use your CPAP device due to these issues, discuss your individual health situation with a health care provider, such as your primary care physician or sleep doctor.
- At this time, if you are not experiencing these issues, then the FDA does not recommend discontinuing use of these machines.
- Report any concerns about the CPAP machine to the FDA, including unusual smells, sounds, or changes in appearance, and report any concerns to PhilipsExternal Link Disclaimer.
Device Description
The Philips DreamStation 2 CPAP machine delivers positive airway pressure for treatment of obstructive sleep apnea. It is used at home and in clinical settings.
FDA Actions
The FDA is working with the company to better understand the issue(s) related to the DreamStation 2 CPAP machine and the possible underlying cause(s) and will update the public with new information, as appropriate.
The FDA is also in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly.
Reporting Problems with Your Device
If you think there may be a problem with your CPAP machine, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
Additional Resources
Philips Response:
https://www.philips.com/a-w/about/news/archive/standard/news/press/2023/20231129-philips-statement-on-recent-fda-safety-notification-related-to-dreamstation-2.html
Nov 29, 2023
Philips statement on recent FDA safety notification related to DreamStation 2
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 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.
Dreamstation 2 User Manual:
Device setup including the heated humidifier begins on page 16.