HQ Team
February 1, 2024: Philips recalled ventilators and machines for treating obstructive sleep apnea have caused 561 deaths, according to the USFDA.
“Since April 2021, the FDA has received more than 116,000 MDRs, including 561 reports of death, reportedly associated with the…suspected foam breakdown,” according to an FDA statement.
The US Department of Justice is probing the handling of the recall. The polyester-based polyurethane foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said on January 29, Philips had agreed to the terms of a consent decree with the US Department of Justice.
“The consent decree is being finalized and will be submitted to the relevant US court for approval. Until there is a finalized agreement that has been signed and filed with the court, we cannot comment further,” he quoted from a Philips statement.
Business in the US
The consent decree primarily focuses on Philips Respironics’ business operations in the US. The decree will provide Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and restore the business, according to a Philips statement on January 29
Until the relevant requirements of the consent decree are met, Philips Respironics will not sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the US. Outside the US, Philips Respironics will continue to provide new sleep and respiratory care devices, accessories, consumables, and replacement parts.
As a consequence of addressing this consent decree, which is a multi-year plan, Philips recorded a provision of 363 million euros in Q4 2023 that relates to remediation activities, inventory write-downs and onerous contract provisions.
Philips submitted 30 medical device reports between 2011 and April 2021 where they identified the foam breakdown. Eight of those reports were from the US. “There were no reports of patient injury or death among those 30 MDRs.”
7,000 MDRs
In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns about foam breakdown in certain ventilators, and machines. The company formally submitted their Report of Correction and Removal in June 2021.
The health regulator reported receiving over 7,000 medical device reports between July and September 2023.
*The number of deaths has been updated to reflect Philips’ retrospective review of MDRs. A wide range of injuries has been reported in these medical device reports, 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,” the FDA stated.
The reports were a valuable source of information, but 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.
Because of these limitations, the reports comprise only one of the FDA’s several important post-market surveillance data sources. “These reports, along with data from other sources, can contribute important information to a medical device’s benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.”
