Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device at his home Thursday, Oct. 20, 2022, in Marysville, Ohio.
Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected. . The recalled devices include Dreamstation and SystemOne CPAP models and several other Philips machines, including Trilogy ventilators.to expand its communication effort, including “clearer information about the health risks of its products.” Regulators estimated then that only half of U.S. consumers affected had registered with the company.
“Once I got off their machine, all of that cleared right up,” said Reed, 62, who obtained a competitor’s device after several months. Like other users, Reed can’t definitively prove his problems were caused by Philips’ device. Medical device companies typically conduct recalls voluntarily, and former FDA officials say the agency has never actually used its authority to force additional steps.
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