by
John R. Fischer, Senior Reporter | February 05, 2024
The FDA says it has received over 500 reported deaths that are linked to Philips recalled respirators.
Following Philips’ agreement on a consent decree with the U.S. Justice Department last week, the FDA has revealed that the company’s ventilators and respirators recalled in 2021 have been linked to over 500 reported deaths.
The agency says that it has documented 561 deaths related to the use of these devices, and that 7,000 medical device reports made between July and September in 2023 alone included 111 deaths,
according to Reuters.
The FDA cautioned that the reports had limitations and that underreporting, inaccuracies, and lack of verification made it impossible to determine if the devices alone were responsible for the adverse events.
"Philips investigates all received complaints and allegations of malfunction, serious injury, or death ... and has found no conclusive data linking these devices and the deaths reported," said Philips in a statement.
The company
recalled 5.5 million bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines in June 2021 after discovering that the polyester-based polyurethane sound abatement foam within them could break down and release particles that can enter a device’s air pathway and become toxic, possibly causing cancer.
The U.S. Department of Justice
launched an investigation into the matter, including Philips’ handling of its Class I recall for the devices. The company has faced a barrage of lawsuits from several patients who claim that using the devices harmed them.
In the consent decree it signed, the company
agreed not to sell the devices over the next few years in the U.S. until it meets the compliance requirements outlined in the decree. Currently, it is only servicing sleep and respiratory care devices already used by American healthcare providers and patients and supplying accessories, consumables, and replacement parts. It is still selling the products in other countries.
It says it continues to receive complaints about its sleep apnea devices and files them as medical device reports with the FDA.
Since 2021, the company has been the subject of additional recalls since that time, including for sleep masks used with its BiPAP and CPAP machines in 2022, and for certain Trilogy ventilators in 2023.
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