AMSTERDAM (June 14, 2021)—On Monday, Philips announced it is voluntarily recalling nearly 4 million CPAP machines and noninvasive ventilators to ensure patient safety in consultation with regulatory agencies. Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices.
The recall affects specific Philips bi-level positive airway pressure (Bi-Level PAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The company identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family.
Eighty percent of the affected devices are CPAP machines for sleep apnea patients, company spokesman Steve Link said in a statement to Reuters. Users of those devices have been advised to halt use and consult their physician. Philips provided a list of the affected devices here.
Philips has produced millions of bi-level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.
Philips said it decided to voluntarily issue a recall notification to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” Frans van Houten, CEO of Royal Philips, said in a company news relase. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”
Home medical equipment providers can find information about how to help consumers obtain a replacement or repair for their affected device here.
