NOTICE: FDA Fire Safety Alert Dreamstation 2

[Gideon]

FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines

https://www.fda.gov/news-events/press-an...p-machines

• U.S. Food and Drug Administration
  

IN THIS SECTION

 

1. Safety Communications
   

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  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.
    
• [size=undefined]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.[/size]
  
• [size=undefined]Unplug the CPAP machine and do not use it if:[/size]
  • 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
FDA Press Release

 
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• Content current as of:
  11/28/2023
  
  
• Regulated Product(s)
  
  • Medical Devices
    

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[sauerkraut]

Thanks for posting this Gideon ..
Wow !!  Another problem with Philips CPAP machines ..
I feel for the folks using them !!  How can they sleep with a fire hazard
next to the bed ??

[paulag1955]

One begins to wonder if Phillips should be allowed to make medical equipment.

[Jay51]

Another way to keep it cooler is to put it on a "mesh-like" table to let it get more airflow from the bottom side.  Instead of a solid table top, the top has holes in it to better ventilate (kind of like these laptop holders made of wire mesh that lets the bottom of the laptop breathe better with more airflow).  Or one of those wire storage racks.  Can even direct a house fan towards it to radiate more of the blowers heat.

[SuperSleeper]

All I can say about this is "ARGH!!!"    

The recall replacement machines are now going to be recalled?   Wow.  Just wow.

[srlevine1]

IMPORTANT

Philips CPAP Machine May Catch Fire, Cause Burns, FDA Warns

Agency received reports of equipment overheating

The Food and Drug Administration warned patients to monitor their Philips DreamStation 2 CPAP machines for overheating after an increase in fires, smoke and burns caused by the device.


The agency received over 270 complaints between Aug. 1 and Nov. 15, a significant jump from the fewer than 30 received in the previous three years.

The warning comes some two years after Philips recalled about 10.9 million sleep apnea devices following more than 1,200 complaints of degraded foam, which released harmful gases and particles into users’ airways. The company has since replaced over 2.5 million devices, including DreamStation 1 CPAP machines, with the DreamStation 2 machines. The issue with the DreamStation 2 may stem from an electrical or mechanical malfunction rather than problems with the foam, the FDA said.

Advice for patients


The FDA suggests patients follow the instructions in the user manual, specifically:

• Keep the machine on a firm, flat surface
  

• Keep the machine away from carpet, fabric or other flammable material
  

• Carefully clean the machine
  

• Empty the machine’s water reservoir
  

• To reduce the risk of burns, let the heater plate and water tank cool off for approximately 15 minutes before removing the tank.
  

• Inspect and examine the machine before and after each use for unusual smells or changes in appearance. Some problems have been noticed only when the machine is running, so note any differences in the machine as you prepare for bed or before you fall asleep.
  

• Stop using the machine if you detect a burning smell, notice a change in appearance or performance, experience water spillage, or hear unusual sounds.
  

The FDA does not advise anyone to stop using their CPAP device unless there is an issue. The agency asks that you report any concerns, such as unusual smells, sounds or changes in appearance, to the FDA and Philips. Meanwhile, officials are working with Philips to better understand the issue and will update the public when new information is available.

[MisterMac]

I have a Dreamstation 2 that I received from Philips through the pain in the a** procedures to replace my recalled System One. Am I concerned about this issue with the Dreamstation 2? Absolutely. Am I panicking? Absolutely not. I am glad that the FDA is being proactive about the issue early on, as I feel they weren't with the issue with the foam degradation on the previous Philips device recall. I am NOT a Philips fanboy, but It is early and we do not know if the issue is a defect with the devices or users not using the devices properly. I will be closely following this issue.

[Gideon]

IMHO with that many reports of similar issues it is extremely unlikely that it is insignificant. Design should be easily able to handle pretty much anything approaching normal use. That should include humidifier running with a dry tank.

While this info is not specific, in time I expect a DS2 recall.

I suspect the DS2 was rushed to production based on its official release date of the day after the major Philips recall as their solution to the foam failed machines.

[MisterMac]

You make good points and I am not saying the issues are insignificant. But I am not getting overly alarmed until there is more information from the FDA.

[brianc18t]

"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."

Kind of hard to do while one is sleeping!!!