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In a recently submitted medical device report, Philips reported 14 serious injuries and 0 deaths related to the use of the recalled masks.
According to an announcement from the FDA, Philips Respironics has recalled several of its masks used with bilevel positive airway pressure (BPAP) machines and continuous positive airway pressure (CPAP) machines because of a serious safety concern. Specifically, the recalled masks are for patients weighing more than 66 lbs, except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP, which are for patients 7 years and older weighing more than 40 lbs.1,2
The recalled masks, which included the Amara View Full Face Mask, DreamWisp Nasal Mask, Wisp and Wisp Youth Nasal Masks, and Therapy Mask 3100 NC/SP, each have magnetic headgear clips to hold them in place. In the FDA report, it was noted that these magnets can cause potential injuries or death, as well as interfere with certain metallic medical devices and metallic objects in the body.
Those with pacemakers, implantable cardioverter defibrillators, metallic stents, neurostimulators, magnetic metallic implants, cerebrospinal fluid (CSF) shunts, and aneurysm clips may be at potential risk with these recalled masks. The FDA noted several other metallic medical devices or objects that present a potential risk, including intracranial aneurysm intravascular flow disruption devices, ocular implants, certain contact lenses with metal, magnetic denture attachments, implantable ports and pumps, and others.
More than 17 million masks containing magnetic clips have been distributed by Philips to date. As of August 30, 2022, in a submitted medical device report (MDR), Philips reported 14 serious injuries and 0 deaths related to the use of the recalled masks. The reported injuries included pacemaker failure leading to pacemaker replacement, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillator, arrhythmia, cognitive changes, headaches, change in heartrate, convulsions, and irregular blood pressure.
Stringent governmental measures predicted lower global scores on Pittsburgh Sleep Quality Index, while, albeit to a small extent, less restrictive measures were related to worse subjective sleep quality.
In a company statement, Philips wrote, "Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a nonmagnetic mask if available, for continued therapy. Patients should properly dispose of the mask that has magnets after an alternative is obtained."2
Fatal injury for those with CSF and ventriculoperitoneal shunts who use the recalled masks may be caused by potential increased pressure on the eye or brain. Similarly fatal injury for those using aneurysm clips may occur if patients have disrupted suture lines or clip separation; those with pacemakers may experience heart block or irregular heartbeat can occur if moved, also considered potentially fatal. For patients with neurostimulators, movement of these devices induced by the magnets may result in compression of the brain, seizures, or lead migration, which may be fatal as well.
The FDA noted that it will continue to work with Philips to ensure the company takes the appropriate steps to correct the recalled devices, Additionally, the agency will review the strategy the company proposes to address the problem and may take additional actions as appropriate. Above all, the FDA plans to keep the public informed if significant new information becomes available.
