On Friday, the Food and Drug Administration issued a Class I recall for certain Philips CPAP and BiPAP respirators that were refurbished in an earlier recall, the latest in a string of troubles for the medical device giant. The machines were incorrectly programmed with the wrong serial numbers, leaving some users without the right prescription settings and running the risk that the machines “fail to deliver any therapy at all.”
Because consumers may not be aware the devices are not working correctly, the malfunctioning respirators could result in “respiratory failure, heart failure, serious injury, and death,” regulators warned. The FDA said Philips had received 43 complaints about the issue, but had not received reports of injuries or deaths. The DreamStation respirators are used by patients at home and in health care settings.
The company sent a notice to affected customers in the U.S. and France on February 10 that included the list of serial numbers for the 1,200 affected devices. In an emailed statement, Philips said the company had shipped replacement devices to more than half of the users affected by the serial number error as of April 7.
This is the third FDA recall associated with Philips respirators. The initial June 2021 Philips recall over soundproofing foam that released irritating chemicals and foam particles inside the respirators affected over 10 million CPAP machines, BPAP machines, and ventilators in the U.S. alone. The recall was the culmination of over a decade of complaints from respirator users and confirmed many users’ suspicions about the product; from April 2021 to December 2022, the FDA received over 98,000 adverse event reports and 346 reports of deaths associated with the devices, though it remains unclear whether the deaths were associated with the respirator use.
In an unusual move, the FDA forced the company to contact all affected users, after determining that the company’s outreach had been insufficient. The agency took the equally rare step of threatening to force the company to offer replacement devices, repairs, or refunds, as STAT reported last year. In November 2022, the FDA reported that the foam used to refurbish recalled machines could detach from its backing and block the machine’s air inlet, leading to a second recall.
“[The serial number] matter does not impact the remediation of sleep therapy devices under the June 2021 field safety notice,” said Steve Klink, Philips’ global press office and industry analyst relations head, in an emailed statement. “We regret the concern that this field safety notice for specific sleep therapy and ventilator devices have caused for patients and care providers.”