Philips Respironics Issues Alert Over ‘Serious Injury’ Risk Posed By Magnets In Masks

Philips Respironics is alerting users about certain sleep therapy masks that may pose risks of “serious injury” due to their magnet component.

The problem with the masks is that they have magnetic headgear clips that could potentially affect implanted medical devices with metal on them, the U.S. Food and Drug Administration (FDA) noted in a news release.

These masks are worn with Philips bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, which are used to help people who have sleep apnea. The magnet on them could affect both a user or someone within close vicinity who has an implanted metal object such as a pacemaker, aneurysm clip or metallic gastrointestinal clip, according to the company announcement on the FDA website.

“The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices,” the agency said in the news release.

As of Aug. 30, the company has received 14 reports of “serious injury” related to the use of the masks, including arrhythmia, seizures and cognitive issues. Incidents in which a defibrillator stopped working periodically and a pacemaker required replacement after failing were also logged.

The notification affects the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks. In total, 17 million of these masks have been distributed. Photos of the masks are available on the FDA website.

“(T)his is a voluntary notification to inform users of specific sleep therapy masks containing such magnetic clips of the updated instructions and labeling,” Philips Respironics said in an FAQs document uploaded on its website. “The already present warnings have been strengthened and contraindications have been added.”

According to the company, patients can keep using the masks “according to the updated instructions and labeling” if they and the people around them don’t have implanted medical devices with metal.

However, the affected masks should not be used if the patient or those in close proximity to them have devices that are contraindicated against the magnets. In their case, they are being advised to contact their doctors to see if there are other masks that they can use.

“In the interim, switch to a non-magnetic mask if available, for continued therapy,” the company announcement noted. “Patients should properly dispose of the mask that has magnets after an alternative is obtained.”

A list of some of these implanted devices is available on the FDA website.

This current issuance is unrelated to the June 2021 Philips Respironics recall, according to the FDA. Only recently, the company also recalled certain BiPAP devices due to a problem with plastic contamination.

“We strongly encourage providers and at-risk patients to review this important safety information and follow our recommended actions to reduce the potential for harm from these products,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the news release.

Those with questions about the issuance may contact Philips Respironics at 1-800-345-6443. Adverse events related to the masks may also be reported to the FDA via 1-800-FDA-1088.