The FDA issued an Update on the Philips CPAP recall to report a significant increase in the number of injuries and deaths.
Last year, Philips recalled about 15 million CPAP machines, BiPAPs, and ventilators because they contained a toxic sound-abatement foam that could disintegrate and release small particles into the air path.
Thousand of people who used the machines may have breathed in tiny particles of the toxic foam, resulting in serious health problems.
Between April 2021 and April 30, 2022, the FDA said it received more than 21,000 medical device reports, including 124 deaths, involving health problems that are linked to recalled Philips CPAP machines.
The reports involve a wide range of injuries, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.
However, the FDA cautioned that reports have limitations, such as “under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use,” according to the update.
