ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices
December 20 2023 - 4:05PM
ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field
action to update its guides for all masks with magnets to inform
users about potential magnetic interference when magnets are near
certain implants and medical devices in the body. This voluntary
field correction does not require a return of a mask with magnets
unless the patient is contraindicated. All ResMed masks containing
magnets are safe when used in accordance with the Field Safety
Notice and updated Instructions for Use in the guides of affected
masks.
A patient is contraindicated 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).
Patients using the masks with magnets or anyone in close
physical contact with mask magnets should keep the magnets at a
safe distance of 6 inches (150 mm) away from implants or medical
devices that may be adversely impacted by magnetic interference.
Refer to the ResMed Magnet Update website for more information
about the updates issued to contraindications and warning
labels.
ResMed is notifying affected customers and providing guidance
for specific actions. ResMed has provided a patient letter to
healthcare providers that includes additional information regarding
the contraindications and warnings for patients with the affected
medical implants or devices. Patients should consult their
physician and/or manufacturer of their implant or other medical
device if they require additional information on the potential
adverse effects of magnetic fields for their device.
For patients where they, or anyone in close physical contact, do
not have a contraindicated device, no action is needed.
ResMed masks with magnets were distributed nationwide and
globally from 2014 to November 2023. ResMed has submitted five
reports of serious harm (medical intervention/hospitalization) that
were potentially related to magnetic interference of a mask with a
magnet with an implanted device to relevant regulatory authorities.
To date, no permanent injuries or deaths have been reported.
The impacted Mask with Magnet product(s) can be identified by
the model number: AirFit N10, AirFit F20, AirTouch F20, AirFit N20,
AirTouch N20, AirFit F30, AirFit F30i on the cushion or frame of
the masks.
ResMed voluntarily updated its contraindications and warning
labels in response to new information obtained through post-market
surveillance and industry practices. ResMed has notified the FDA
and other global regulators where required.
Consumers with questions may contact ResMed at 1-800-424-0737,
online at www.resmed.com/contact, or visit the Resmed Magnet Update
website for more information. Adverse events experienced with the
use of this product may be reported to the FDA's MedWatch Adverse
Event Reporting program either online, by regular mail or fax.
1-800-332-1088 to request a form.
About ResMedAt ResMed (NYSE: RMD, ASX: RMD), we
pioneer innovative solutions that treat and keep people out of the
hospital, empowering them to live healthier, higher-quality lives.
Our digital health technologies and cloud-connected medical devices
transform care for people with sleep apnea, COPD, and other chronic
diseases. Our comprehensive out-of-hospital software platforms
support the professionals and caregivers who help people stay
healthy in the home or care setting of their choice. By enabling
better care, we improve quality of life, reduce the impact of
chronic disease, and lower costs for consumers and healthcare
systems in more than 140 countries. To learn more, visit ResMed.com
and follow @ResMed.
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