FDA Warns About CPAP Machine Overheating Risk

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The FDA issued a warning about the DreamStation 2 CPAP Machine, which is used to treat obstructive sleep apnea, due to reports of the device overheating and leading to fires, smoke, and burns.

FDA Warns About Philips Respironics’ DreamStation 2 CPAP Machine: Monitor for Overheating

The US Food and Drug Administration (FDA) has issued a warning to patients and health care providers about the Phillips DreamStation 2 continuous positive airway pressure machines’s (CPAP) thermal issues—and to watch out for overheating as the device has led to fires, smoke, and burns.1

The Phillips DreamStation 2 CPAP machine delivers positive airway pressure for treatment of obstructive sleep apnea at home and in clinical settings. Recently, the FDA had been receiving reports about the device’s overheating. Between August 1, 2023, and November 15, 2023, the FDA received 270 complaints associated with the device.

Customers received the DreamStation 2 CPAP machines as replacements for the recalled DreamStation 1 CPAP machine in June 2021. Issues with the DreamStation 2 CAP machines is still being under review. The agency does not believe the safety issues stem from the foam used in the machine, but possibly related to an electrical or a mechanical malfunction of the machine.

The FDA advises patients, caregivers, and health care providers to follow the manufacturer’s instructions. Recommendations include placing the machine on a firm, flat surface, keeping it away from the carpet, fabric, or other flammable materials, carefully cleaning the machine, emptying the machine’s water reservoir, and allowing the heater plate and water tank to cool for 15 minutes before removing the tank to prevent the risk of burns. If someone touches the heater plate, the heated water, or the humidifier water tank pan, they could burn.

The FDA recommended checking the machine before and after every use for odd smells or changes in appearance—issues may only be visible when the machine is running, so customers should inspect before going to bed.

Moreover, the FDA instructed to unplug the machine and stop using if there is a burning smell, a change in appearance of the machine, unexplained changes to the machine’s performance, water spilling into the machine, and the machine making unusual sounds.

If the user does not experience any of these issues, the FDA does not recommend discontinuing the machine. Though, if they start to experience unusual smells, sounds, and changes in appearance, then they should report to the FDA or to Philips.

The FDA is currently looking to find the underlying cause for Phillips DreamStation 2 CPAP’s overheating.

“The FDA is committed to assuring this new safety issue is resolved expeditiously. We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press release. “We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.”2

References

  1. Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication. The U.S. Food and Drug Administration. November 28, 2023. https://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication. Accessed November 28, 2023.
  2. FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines. The U.S. Food and Drug Administration. November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-cautions-public-safety-issue-philips-dreamstation-2-cpap-machines. Accessed November 28, 2023.
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