Philips-brand CPAP machines, supposed to help sleep apnea machines breath at night, was instead killing them. The FDA posted a safety communication about the devices, 5 million of which were recalled in 2021 but which are only now being removed from the market. They are now tied to 561 deaths. The polyurethane foam used as seals in Philips Respironics ventilators, BiPAP machines, and CPAP machines would break down over time break free and be send into the user’s body.
A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients.
Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use.
Philips has settled with the FDA and the Justice Department (“roughly $400 million,” reports CBS News) and with some users (“at least $479 million”) over the bedside devices, which were “repaired” but recalled again later.
30 million people have sleep apnea in the U.S. and a about one in six of them used a Philips machine.
Previously: Thousands of sleep apnea sufferers rely on a lone Australian CPAP hacker to stay healthy