Millions of CPAP and BiPAP masks recalled, serious safety issue

14 serious injuries reported
Millions Of Cpap And Bipap Masks Recalled Serious Safety Issue
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The USDA and FDA issued an alert for millions of CPAP and BiPAP masks due to a “serious safety concern.”

“This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.”

The U.S. Food and Drug Administration tells patients, caregivers and health care providers to check and see whether their mask is one of the recalled Philips masks. The recalled masks are worn by a person when using a BiPAP or CPAP machine and have magnets that connect the mask components to hold the device in place.

The magnets in those masks could potentially cause injury or death to people who use them, or people near a person using the recalled mask, have certain implanted metallic medical devices or metallic objects in the body. You can find a list of examples of metallic objects here.

Recalled Masks

The recalled Philips masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. The recalled masks are for single-patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg).

  • Figure 1: Amara View Full Face Mask
  • Figure 2: DreamWisp Nasal Mask
  • Figure 3: DreamWear Full Face Mask
  • Figure 4: Wisp and Wisp Youth Nasal Mask
  • Figure 5: Therapy Mask 3100 NC/SP

This recall is not associated with the polyester-based polyurethane (PE-PUR) foam issue for certain ventilators, BiPAP machines and CPAP machines recalled in June 2021. However, this recall affects masks used with some of the devices that were recalled in June 2021.

Reported Injuries, Information from USDA

To date, Philips reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks.

Recommendations for Patients and Caregivers from FDA

  • Stop use of the recalled mask and switch to a non-magnetic mask if available, if you or someone near you when using the recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.
  • Ensure the recalled mask is kept at least 6 inches away from metallic medical implants, metallic objects in the body, and medical devices that can be impacted by the magnetic fields.
  • Consult with your health care provider to determine if another mask can be used for therapy and to decide if the plan for your care and treatment should change as a result of this safety issue.
  • Contact your health care provider immediately, if you experience any issues related to your medical device and report the issue through the FDA’s MedWatch Voluntary Reporting Form.
  • Contact Philips Respironics’ customer service at 1-800-345-6443 or visit their website at www.usa.philips.comExternal Link Disclaimer for more information about non-magnetic mask options.
  • Properly dispose of the recalled mask after you have another alternative mask.
  • You may continue using the mask, if you or someone near you when using the recalled mask, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.

Recommedations for Health Care Providers from FDA

  • Tell patients to stop use of the recalled mask and switch to a non-magnetic mask if available, if they or someone near them when using a recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.
  • Ensure the recalled mask is kept at least 6 inches away from metallic medical implants, metallic objects in the body, or medical devices that can be impacted by the magnetic fields.
  • Properly dispose of the recalled mask.
  • Discuss the health risks associated with using the recalled masks with patients who may at risk for potential injury or death due to magnets affecting the function or inducing movement of certain implanted metallic medical devices or metallic objects in the body.
  • Do not prescribe use of the recalled masks on patients who have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks. Prescribers should also ask about any other people who may be at risk for injury or death if they are near a recalled mask while it is being used.
  • If you have any problems with a recalled mask or if you treat a patient who has been affected, report the issue through the FDA’s MedWatch Voluntary Reporting Form.

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