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Dreamstation 2

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health2 years ago

FDA Identifies Safety Issue with Philips CPAP Machines, Shares Plummet

Shares of Dutch technology company Philips fell over 6% after the US FDA alerted patients to a new safety issue with machines used for the treatment of obstructive sleep apnea. The problem involves the heating element in the humidifier of the "DreamStation 2" sleep therapy device. Philips had already conducted a review that found 270 complaints over the past three years and had flagged the matter with the FDA. The agency received reports of thermal issues such as fire, smoke, burns, and overheating while using Philips' DreamStation 2 CPAP machines. Around a million DreamStation 2 machines are on the market, and they can continue to be used as long as safety instructions are followed.

health2 years ago

FDA Warns of Safety Issues with Philips' DreamStation 2 CPAP Machines

The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding Philips Respironics' DreamStation 2 CPAP machines used for treating obstructive sleep apnea. The FDA has received reports of thermal issues with the machines, including fire, smoke, burns, and overheating, leading to patient injuries. The agency is in discussions with Philips about mitigation strategies and is urging users to carefully monitor the machines for signs of overheating. This safety issue is separate from the June 2021 recall of Philips sleep therapy and respirator machines. The FDA believes the thermal issues may be due to electrical and/or mechanical malfunctions and will provide updates as more information becomes available.