Urgent Product Defect Correction

In response to new information from latest industry practices and global safety data, ResMed is updating the Contraindications and Warnings relating to magnetic interference, in their User Guides to instruct patients on the safe use of ResMed masks with magnets.

Magnets are used in some ResMed masks to provide a simple and easy way for patients to attach and detach the headgear to the mask frame, although if you or anyone in close physical contact while using the mask (i.e. bed partner), have the following then this notice applies to you.

Updated Contraindications (i.e. condition where the mask is not to be used).
• 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)

Updated Warning
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.

Note, not all models or variants of medical devices listed in the contraindications are affected by external magnetic fields. If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your physician/doctor.

ResMed’s masks with magnets are safe when used in accordance with the updated Instructions for Use including the Contraindications and Warnings. When a magnet comes close to certain medical implants/devices (less than 6 inches / 150mm) there is potential for magnetic interference to change:
• the function of an implant/medical device
• the position of implants made of ferromagnetic material

In rare circumstances, this can lead to serious injury or death. Contraindicated patients can avoid the potential harm from magnetic interference by using an alternative mask without magnets.
All other patients using ResMed masks with magnets can continue to use the mask following the updated Instructions for Use.

Field Safety Notice - Patient Letter

ResMed Masks with Magnets Guide

Replacement Mask Request Form

For more information or advice on CPAP Masks, please contact your nearest store or the CPAP Direct Support Team on 1300 800 985 or support@cpap.com.au.