Medical device manufacturer, ResMed Limited, has issued a medical device safety alert concerning the following ResMed masks with magnets: AirFit N20, AirFit N20 for Her, AirTouch F20, AirTouch F20 for Her, AirFit F30, AirFit F30i, AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her, AirTouch N20, AirTouch N20 for Her, AirFit F20 NV [HKMD No.: 190343].
The manufacturer is updating the Contraindications and Warnings in our User Guides to instruct patients on the safe use of ResMed masks with magnets. The changes are as follow:
- Contraindications: conditions under which the mask is not to be used.
- Masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have the following:
- Active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
- Metallic implants/objects containing ferromagnetic material (i.e., 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)
- Warnings: identify a possible hazard and provide information on how to safely use the mask.
- “Keep the mask magnets at a safe distance of at least 6 inches (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference. This warning applies to you or anyone in close physical contact with your mask. The magnets are in the frame and lower headgear clips, with a magnetic field strength of up to 400mT. When worn, they connect to secure the mask but may inadvertently detach while asleep”.
- “Implants/medical devices, including those listed within contraindications, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials that attract/repel to magnetic fields (some metallic implants, e.g., contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices). Consult your physician and manufacturer of your implant / other medical device for information on the potential adverse effects of magnetic fields.”
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Nov 2023