The FDA said that it has received reports that the machines can overheat and cause “thermal issues such as fire, smoke, burns and other signs of overheating while people are using” the devices.
The CPAP, or continuous positive airway pressure, machine is used to treat obstructive sleep apnea at home and in clinical settings.
Between Aug. 1 and Nov. 15, the FDA received more than 270 reports of problems with the DreamStation 2, compared with fewer than 30 over three years.
Some DreamStation 2 devices were prescribed after the DreamStation 1 CPAP was recalled.
The FDA is investigating what is causing the overheating but said that it may be an electrical or mechanical malfunction.
The FDA said that users of the machines should follow the instructions in the device’s user manual including:
- Putting it on a firm, flat surface.
- Keeping it away from carpet, fabric or other flammable materials.
- Cleaning the machine.
- Emptying the water reservoir.
- Letting the machine’s heater plate and water tank to cool for 15 minutes before removing the tank..
- Inspecting the machine for damage before and after each use..
- Keeping an eye out for unusual smells or changes in appearance..
If you notice any issues, the FDA said you should unplug the machine, especially if you smell burning smoke or unusual odors, notice changes to the appearance of the machine or how it performs, or if you hear unusual sounds coming from it.
The FDA and Philips are working together to find out what is causing the issue and any further steps if needed.
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