Even as Philips nears the end of the repair-and-replace program for its recall of 5.5 million respiratory devices, complaints about the machines are still rolling in.
According to an updated tally published by the FDA this month, as of the end of 2022, the agency has received more than 98,000 medical device reports (MDRs) in response to the recall. The count stretches back to April 2021, when Philips first publicized the issues with many of its CPAP and BiPAP machines and other devices that would ultimately spark the official recall in June 2021.
The most recent additions to the tally include more than 8,000 MDRs received between Nov. 1 and Dec. 31. Those complaints include 82 reported deaths; in total, 346 deaths have now been reported in response to the recall.
Both the FDA and Philips noted that MDRs represent an unaudited pool of complaints that haven’t been confirmed to be directly linked to the recall at hand.
“The vast majority (93%) of the approximately 99,000 MDRs filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury,” Philips said in a release published alongside the FDA update. “Philips Respironics investigates all allegations of technical malfunction 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 certain of these MDRs.”
In December, the company shared the results of safety tests covering the majority of the devices included in the recall, which centers on the breakdown of sound- and vibration-muffling foam found in many of Philips’ respiratory support machines. According to Philips, the tests suggested that particles released by the disintegrating foam were “unlikely to result in an appreciable harm to health in patients” and that volatile organic compounds released by the foam produced “no appreciable harm to health.”
During a call with reporters at the time, Jan Kimpen, M.D., Philips’ chief medical officer, said the company had yet to find “a direct or indirect correlation” between the mounting MDRs and use of the recalled devices.
Despite those claims, Philips has continued its crusade to repair or replace all machines included in the recall. The company’s update this month confirmed that it has completed “more than 90% of the production required for the delivery of replacement devices to patients.” The remediation program is expected to be completed sometime this year.
In the meantime, the devicemaker is still under investigation by the U.S. Department of Justice and in ongoing conversations with the FDA over a proposed consent decree. It’s also the subject of hundreds of class-action lawsuits that have been consolidated into a single multidistrict litigation action in a Pennsylvania district court.