In the first year since Philips began taking precautions against a suspected safety issue with many of its ventilators and CPAP and BiPAP machines last April, the issue has sparked more than 21,000 complaints, including more than 120 reported deaths.
The FDA shared the one-year tally in an update to a safety communication it originally issued in November to provide additional information about the issue, which evolved into a formal safety recall in June 2021 and was given the FDA’s most serious rating a month later.
Philips’ first mention of the issue came at the end of April 2021. In its quarterly report that month, CEO Frans van Houten said in a statement, “Regretfully, we have identified a quality issue in a component that is used in certain sleep and respiratory care products, and are initiating all precautionary actions to address this issue, for which we have taken a €250 million provision.”
The report went on to share that, based on reports from users and its own testing, the Dutch medtech had discovered a possible issue with the sound abatement foam used in many of its respiratory devices. Just a few weeks later, the formal recall notice described how as the foam breaks down over time, it can release potentially harmful chemicals and black debris into the user’s airflow.
When the recall began, it included devices that had been distributed up until April 26, 2021.
In the decade between 2011 and that point, according to the FDA’s latest update, Philips had turned over only 30 medical device reports associated with the foam’s deterioration. These MDRs include mandatory and voluntary reports of safety issues, injuries and deaths from patients, consumers and healthcare providers. Only eight of the initial 30 reports came from the U.S., and none linked any injuries or deaths to the issue.
From the end of April 2021 to April 30 of this year, however, the number of safety reports potentially connected to the recall skyrocketed. The FDA said it received more than 21,000 complaints, including mandatory reports from Philips and voluntary ones from users and healthcare professionals. They detailed a wide range of injuries and adverse effects—including cancer, pneumonia, asthma, infection, headache, nodules and chest pain, among others—plus 124 patient deaths.
Though undoubtedly a serious indicator of the many potential risks of the sound abatement foam’s deterioration, the FDA noted that not all 21,000 MDRs are definitively linked to the issue, citing “under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about frequency of device use.”
Still, the agency said it continues to take the reports into account while determining the severity of a recall and calculating whether an affected device’s benefits outweigh the risks.
As Philips approaches the one-year anniversary of its official recall notice, the company is still falling behind the FDA’s preferred timeline for its program to repair and replace the 5.2 million affected devices.
Earlier this month, the regulator said it was considering issuing an order that would force Philips to repair, replace or refund all of the machines. Though the company has already begun that process, it’s been slow going: Philips told Fierce Medtech that it has so far produced 1.1 million replacement devices and repair kits, but is still expecting to complete the “vast majority” of the repair-and-replace program by the end of this year.
The FDA said Philips opted not to call for an informal hearing regarding the proposed order. Instead, it plans to provide a written response, which the FDA will consider in deciding whether to issue the formal order.
That proposal came just a few weeks after the FDA issued another order, this one forcing Philips to immediately notify all users of the affected machines, the healthcare providers who prescribe them and the medical equipment suppliers, distributors and retailers who sell them about the recall. The order was meant to rectify what the agency classified as Philips’ “inadequate” notification efforts to that point.