ResMed Magnet Masks- Urgent Field Notice

About the Notice:

ResMed is updating its existing contraindications and warnings to further inform patients and healthcare professionals on the safe use of ResMed masks with magnets. This is in response to new information obtained through post-market surveillance and industry practices related to possible magnetic interference when in close proximity to certain medical devices. Update to Contraindication In an update to the previously contraindicated metallic aneurysm hemostatic clips in the head and metallic splinters in one or both eyes following a penetrating eye injury, ResMed is further contraindicating the use of its masks with magnets for patients where they, or anyone in close physical contact while using the mask (e.g., bed partner), 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)

Product numbers/models that are affected:

Item number	Item Description
63331	AirFit F30i Complete System - S/Std
63333	AirFit F30i Complete System - W/Std
63330	AirFit F30i Complete System - S/Sml
63332	AirFit F30i Complete System - M/Std
63334	AirFit F30i Complete System - M/LGE
63401	AirFit F20 System Medium w/hdgr
64101	AirFit F30 Complete Mask System: Medium
63535	AIRFIT N20 STARTER PK
63501	Airfit N20 System Medium w/hdgr
63301	AIRFIT F30I STD STPK - AMER
63402	Airfit F20 System Large w/hdgr
63450	AIRFIT F20 STARTER PACK

Actions to be taken:

Contraindicated patients using a ResMed mask with magnets If you, or anyone in close physical contact while using the mask (e.g. bed partner),have an active medical implant or metallic implanted object that is identified within the Contraindications above:

• Replace your mask containing magnets with an alternative mask without magnets in a timely manner. Contact your mask provider for alternative mask options.

Note, ResMed is making our masks without magnets available to your mask provider for replacement.

• If an alternative mask is not available, consult your physician/doctor for appropriate next steps regarding your therapy.
• Dispose of the mask with magnets after you receive an alternative mask.

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 a medical device/implant falls under the Contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular device, please contact your physician/doctor. All other patients using a ResMed mask with magnets

• If you are NOT contraindicated from using a ResMed mask with magnets, you may continue to use the mask, ensuring you follow all user instructions, including the updates described in this letter.
• Importantly, ResMed masks with magnets are to be kept at least 6 inches (150mm) away from implants or medical devices that may be adversely affected by magnetic interference, as described in the updated Warning.

For more information regarding these changes please visit www.resmed.com/magnetupdate.

Reporting an Adverse Event

If you have experienced an adverse event related to the use of ResMed masks with magnets, please visit www.resmed.com/contact or contact your mask provider. Alternatively, adverse events experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail or by fax. 1-800-332-1088 to request a form. Manufacturer ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista 2153 Australia