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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.
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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.
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