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ResMed Magnet Masks - Urgent Field Notice

ResMed is giving more information about the safe use of their magnetic masks by updating existing guidelines. This comes as a response to new insights from post-market monitoring and industry practices concerning potential magnetic interference with specific medical devices. The update includes a stronger warning against using ResMed masks with magnets for individuals with:

  1. Active medical implants sensitive to magnets (e.g., pacemakers, implantable cardioverter defibrillators, neurostimulators, cerebrospinal fluid shunts, insulin/infusion pumps).

  2. Metallic implants or objects containing ferromagnetic material (e.g., aneurysm clips, embolic coils, stents, valves, electrodes, implants for hearing or balance with magnets, ocular implants, metallic splinters in the eye).

Product numbers/models that are affected

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Recommended Course of Action

For patients with contraindications using a ResMed mask equipped with magnets

If you, or someone in close physical proximity (such as a bed partner), possesses an active medical implant or metallic implanted object mentioned in the contraindications:

  • Swiftly replace your magnet-containing mask with an alternative one that lacks magnets.

  • Reach out to your mask provider to explore other mask options.

 

Note: ResMed is supplying your mask provider with magnet-free masks for replacement.

  • In the absence of an alternative mask, seek guidance from your physician/doctor for the appropriate course of action regarding your therapy.

  • Dispose of the magnet-equipped mask once you obtain a replacement.

 

Note: Not all models or variants of medical devices listed in the contraindications are susceptible to external magnetic fields. If uncertain about whether a medical device/implant falls under the contraindications or if you need additional information on the potential adverse effects of magnetic fields for your specific device, please consult your physician/doctor.

For all other patients using a ResMed mask with magnets

If the use of a ResMed mask with magnets is not contraindicated for you, feel free to continue usage while adhering to all provided instructions, including those outlined in this letter.

It is crucial to maintain a minimum distance of 6 inches (150mm) between ResMed masks with magnets and any implants or medical devices susceptible to magnetic interference, as specified in the updated Warning

For more information regarding these changes please visit

www.resmed.com/magnetupdate

To report an adverse event associated with ResMed masks featuring magnets, visit www.resmed.com/contact or reach out to your mask provider. Alternatively, you can report such events to the FDA's MedWatch Adverse Event Reporting program online, via regular mail, or fax. To request a form, call 1-800-332-1088.

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