The US Food and Drug Administration (FDA) provided an update on medical device reports (MDRs) received related to Philips’ recall of breathing machines, revealing that it received an additional 7,000 medical device reports, including 111 new reports of death, between July 1, 2023, and Sept 30, 2023.
These reports are associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam in Philips Respironics ventilators, BiPAP machines, and CPAP machines, which were subject to a recall announced in June 2021.
Since April 2021, the FDA has received more than 116,000 MDRs, including 561 reports of death.
A range of injuries has been reported in these reports, including cancer, pneumonia, asthma, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. The medical device reports received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients.
In a statement to Sleep Review, Philips asserts that its investigations have yet to find conclusive evidence linking the devices to the reported deaths.
“Philips Respironics investigates all received complaints and allegations of malfunction, serious injury, or death,” says Steve Klink, head of global external relations for Philips. “The vast majority (~93%) of the MDRs filed since April 2021 up to and including December 2023 are alleged malfunctions that do not involve reported serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these MDRs.”
| Dates | MDRs Received | Reports of Deaths in MDRs |
| April 1, 2021 – April 30, 2022 | >21,000 | 130* |
| May 1, 2022 – July 31, 2022 | >48,000 | 57* |
| August 1, 2022 – October 31, 2022 | >21,000 | 106* |
| November 1, 2022 – December 31, 2022 | >8,000 | 81* |
| January 1, 2023 – March 31, 2023 | >6,000 | 44* |
| April 1, 2023 – June 30, 2023 | >4,000 | 32 |
| July 1, 2023 – September 30, 2023 | >7,000 | 111 |
Manufacturers, such as Philips, are required to submit MDRs when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
“Philips Respironics’ highest priority is the health and well-being of patients, both in terms of safety and providing replacement devices. Since the initiation of the recall, Philips Respironics focused on providing replacement devices to patients and gaining more clarity about the safety of the devices,” says Klink.
Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.
Editor’s note: The article was updated on Feb 2 with comments from Philips.
