The U.S. Food and Drug Administration (FDA) issued a new safety warning alerting those who use Philips DreamStation 2 CPAP machines to be aware of the potential for overheating. The agency explains that they have received over 270 reports of problems filed by users between August 1 and November 15, 2023, a sharp rise over the past three years.

According to the medical device reports from the manufacturer and facilities that use the machines, these overheating issues have resulted in burns, smoke, and even fires. The FDA says the device’s electrical or mechanical systems might be to blame, causing the CPAP machines to overheat while in use. The FDA and the CPAP company Philips are working together to figure out the exact cause. They will continue to provide updates on this ongoing issue. 

CPAP (continuous positive airway pressure) machines are one of the most common ways to treat sleep apnea, with an estimated 33 million people using them. The machines provide a steady flow of air into the upper airway during sleep to help prevent pauses in breathing and reduced oxygen levels caused by sleep apnea. Without treatment, sleep apnea can lead to serious health complications.

Philips DreamStation CPAP machines have been recalled in the past because of concerns about the devices’ foam. This foam could release harmful chemicals or break down and put users’ safety at risk if the broken-down foam is inhaled or swallowed while the machine is in use. The current safety warning isn’t believed to be related to the CPAP’s foam, according to the FDA. 

If you own a Philips DreamStation 2 CPAP, the FDA recommends reducing the risk of your machine overheating. You can find safety tips in the owner’s manual, including:

  • Keep the CPAP on a hard, flat surface so it can’t tip over and away from flammable objects such as fibers and cleaning products.
  • Follow instructions for keeping the CPAP clean.
  • Empty the water reservoir daily.
  • Let the CPAP’s heater plate and water cool completely before removing the tank. These components can burn you if you touch them while they’re still hot. 

Inspect your CPAP before going to bed to make sure you don’t notice any changes to how it looks or smells. It’s a good idea to look over your machine before and after each use. Check that water hasn’t spilled into the machine itself.  

Unplug the CPAP and don’t use it if you smell burning, see smoke, notice anything unusual in its appearance or sounds, or don’t think it’s working correctly.

Talk with your doctor if you can’t use your CPAP due to these or other concerns related to this report. They can help you come up with a plan so you can continue treating your sleep apnea safely. 

The FDA is encouraging CPAP users to report problems with their machines by contacting the manufacturer and filling out the FDA’s MedWatch Voluntary Reporting Form.

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References
2 Sources

  1. Food and Drug Administration. (2023, November 28). Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication.

    https://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication
  2. National Council on Aging. (October 11, 2023) Sleep Apnea Statistics and Facts You Should Know., Retrieved December 14, 2023 from

    https://www.ncoa.org/adviser/sleep/sleep-apnea-statistics/

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