Royal Philips (NYSE:PHG) today provided an update on the recall for some bi-level PAP and CPAP ventilator devices with a foam component problem.
On April 26, Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices due to potential risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in the devices.
According to a news release, the majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family. The complaint rate registered at 0.03% in 2020, Philips said.
The Amsterdam-based company determined through testing that there are possible risks to users related to the PE-PUR sound abatement foam component, including the possibility of the foam degrading into particles that may enter the device’s air pathway and be ingested by the user.
Additionally, the foam may off-gas certain chemicals and its degradation may be exacerbated by unapproved cleaning methods, such as ozone. High heat and high humidity environments may also contribute to the foam’s degradation.
To date, there have been no reports of death related to the issue. Philips received reports of possible patient impact due to foam degradation but received no reports regarding patient impact related to chemical emissions.
Philips determined the course of action was to issue a recall notification urging customers to discontinue the use of the affected bi-level PAP and CPAP machines. Patients using mechanical ventilator devices should not stop or alter their prescribed therapy until they’ve talked to a physician.
The company said it is working with the relevant regulatory authorities regarding the launch and implementation of the projected correction for the issue, with a plan to replace the current sound abatement foam with new material.
Philips expects that revenue headwinds in its sleep and respiratory care business will be compensated by the performances of its other businesses, electing not to change financial guidances provided with the initial recall announcement.
“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,” Philips CEO Frans van Houten said in the news release. “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.”