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The FDA said it had received reports of people facing thermal issues such as fire, smoke, burns, and other signs of overheating while using Philips' DreamStation 2 CPAP machines.
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
Earlier this year, Dutch medical device maker Royal Philips reached a $1.1 billion deal to settle thousands of claims stemming from a recall in 2021 of millions of its breathing machines like ...
Safety concerns led Philips Respironics to recall millions of respiratory machines. A year later, many are still using them despite the possible risks.
Philips Respironics's products include devices for the diagnosis and treatment of sleep apnea including CPAP and bi-level non-invasive ventilation machines, oxygen concentrators for patients requiring supplemental oxygen, infant apnea monitors for infants at risk of SIDS, asthma treatment solutions and hospital ventilators.
CPAP machines possess a motor that pressurizes room temperature air and delivers it through a hose connected to a mask or tube worn by the patient. This constant stream of air opens and keeps the upper airway unobstructed during inhalation and exhalation. [1] Some CPAP machines have other features as well, such as heated humidifiers.
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