FDA Collects Another 6,000 Complaints – Including 40 Deaths – Linked to Philips’ CPAP Recall
On June 2, the U.S. Food and Drug Administration reported over 6,000 complaints, including 40 deaths, involving Philips’ recalled CPAP and BiPAP machines and ventilators during the first quarter of 2023. The number of medical device reports (MDRs) collected between April 2021 and March 2023 now tops 105,000, with 385 reported deaths. This comes as Philips’ latest safety test results indicate that exposure to the disintegrating polyester-based polyurethane (PE-PUR) foam that sparked the recall, “including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.” The tests also found “low” foam degradation in the CPAP and BiPAP sleep therapy machines that account for around 95% of the recalled devices. The company said, “Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these MDRs. The vast majority (~94%) of the approximately 105,200 MDRs filed since April 2021 up to and including March 2023 are alleged malfunctions that do not involve reported serious injury or death.”
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