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Safety Alert Issued For More Than 17M CPAP, BiPAP Masks Due To Potential Injury Risks

The products included in the safety alert
The products included in the safety alert Photo Credit: FDA/Philips Respironics

A company has issued a safety alert to consumers about certain CPAP and Bi-Level PAP therapy masks due to a potentially serious injury risk.

Philips Respironics announced the updated safety information on Tuesday, Sept. 6, which the company said applies to more than 17 million masks containing magnetic clips that it has distributed.

The company said certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps should not be used by or near those who have metallic implanted devices or metallic objects, like metallic splinters, in their body.

Philips Respironics said as of Tuesday, Aug. 30, it has received 14 reports of patients saying the mask magnets might have impacted their medical devices.

These reports include:

  • Pacemaker interference
  • Pacemaker failure leading to replacement
  • Need for shunt adjustment
  • Resetting of automatic implantable cardioverter defibrillator (AICD)
  • Seizures
  • Defibrillator shutting off periodically
  • Arrhythmia
  • Irregular blood pressure
  • Change in heartbeats
  • Cognitive issues

"Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets," the company said. "Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy."

Find more details about the safety alert here.

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