Sam Brusco, Associate Editor12.21.23
ResMed is conducting a voluntary, global field action to update any of its masks containing magnets due to potential magnetic interference when the magnets are near some implants and devices in the body.
The affected products are AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i.
Contraindicated devices at risk of magnetic interference include:
ResMed said the masks with magnets were safe to use with its updated Instructions for Use. The company advised patients or anyone close to mask magnets should keep the magnets six inches away from implants and devices to avoid adverse impacts on those technologies. The company also urged consulting with their physician/manufacturer about their implant or device to evaluate potential risk of adverse effects.
The company’s masks with magnets were distributed globally from 2014 until November 2023. ResMed reported five reports of medical intervention/hospitalization potentially related to the magnetic interference issue. No permanent injuries or deaths have been reported.
The affected products are AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i.
Contraindicated devices at risk of magnetic interference include:
- Active medical implants (pacemakers, ICDs, neurostimulators, CSF shunts, insulin/infucion pumps)
- Metallic implants/objects with ferromagnetic material (aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)
ResMed said the masks with magnets were safe to use with its updated Instructions for Use. The company advised patients or anyone close to mask magnets should keep the magnets six inches away from implants and devices to avoid adverse impacts on those technologies. The company also urged consulting with their physician/manufacturer about their implant or device to evaluate potential risk of adverse effects.
The company’s masks with magnets were distributed globally from 2014 until November 2023. ResMed reported five reports of medical intervention/hospitalization potentially related to the magnetic interference issue. No permanent injuries or deaths have been reported.