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+--- Thread: [Equipment] Mask recall? (/Thread-Equipment-Mask-recall)
Mask recall? - rltarbu - 01-28-2024
I had a sleep study recently and the tech indicated the ResMed Airfit N20 nasal mask is being recalled and will no longer be available due to the magnets on the facemask which I guess are not good for those with pacemakers. I do not have a pacemaker. Just wondered if anyone else has of heard this and if so what a similar replacement mask would be. I also just ordered and received a bleep eclipse mask which I note also uses magnets so is it in the same boat? Thanks for any information.
RE: Mask recall? - PeaceLoveAndPizza - 01-28-2024
Here is the link to the official FDA recall. If you have medical implants it is recommended to replace with masks that have no magnets, but for the rest it is fine.
https://www.fda.gov/medical-devices/safety-communications/certain-resmed-ltd-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect-certain
RE: Mask recall? - OpalRose - 01-28-2024
Hope you don't mind PeaceLoveAndPizza, I copied an excerpt from the link as it's the first time I realized how extensive the list is... things we usually don't think about.
Excerpt:
Magnets Can Interfere with Certain Implanted Metallic Medical Devices and Metallic Objects in the Body
Potential adverse events can happen in people who use the ResMed mask with magnets, or in people near a person using the mask.
The magnets can potentially cause injury or death if used near people who have certain implanted metallic medical devices or metallic objects in the body, such as:
Pacemakers
Implantable cardioverter defibrillators
Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
Neurostimulators, magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
Cerebral spinal fluid shunts (such as ventriculoperitoneal shunts)
Aneurysm clips
Embolic coils
Intracranial aneurysm intravascular flow disruption devices
Metallic cranial plates, screws, burr hole covers, and bone substitute devices
Ocular implants (such as glaucoma implants and retinal implants)
Certain contact lenses with metal
Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
Dental implants
Implantable ports and pumps (such as insulin pumps)
Metallic splinters in the eye
Metallic shrapnel in the body
If the magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body, the potential risks may include:
For cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.
For aneurysm clips: disrupted suture lines or clip separation, which may be fatal.
For pacemakers: heart block or irregular heartbeat, which may be fatal.
For cardioverter defibrillators: may fail to shock, which may be fatal.
For neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.
RE: Mask recall? - Deborah K. - 01-28-2024
The Bleep website says Eclipse has been FDA approved. They post a warning about use of magnets for people with certain implants or devices:
MAGNETIC WARNING: Magnets used in the Eclipse™ are within ICNIRP guidelines for general public use. The magnetic strength is 65 mT. Ensure the mask is at least 0.8 inches (2 cm) (emphasis is mine) away from any active medical implant or medical device (e.g., pacemaker, defibrillators, neurostimulators, cochlear implants, hearing aids), to avoid possible effects from localized magnetic fields. If patient/household member has magnets or metal in their bodies consult a physician prior to use.
RE: Mask recall? - PeaceLoveAndPizza - 01-28-2024
Opal, thanks for that. It is a rather interesting and extensive list.
Deb, thanks for the Bleep info. I forgot the new ones use magnets.
RE: Mask recall? - BoxcarPete - 01-28-2024
It's exhaustive because they are backpedaling as hard as they can to make sure nobody can come after them about their own issues once they figured out magnets were bad and now that the blood is in the water they need to make sure nothing gets missed. It's a liability thing, doesn't cost them much to add "metal fragments in the eye" to the list, but I've never heard of any magnet smaller than an MRI giving anyone trouble with metal fragments of a size that end up embedded in an eye and are not worth removing.
RE: Mask recall? - rltarbu - 01-28-2024
Thanks for all the responses. I currently don't think I have anything on the list but will be getting a dental implant soon. Not sure how that would be adversely affected though.
RE: Mask recall? - car54 - 01-28-2024
Strange, I just ordered a recalled mask through my DME and there was no mention of a recall.
My feeling is that they will continue to sell them but with added warnings. This was from ResMed's site,
"ResMed’s masks with magnets are safe when used in accordance with the updated instructions for use, including the contraindications and warnings."
I hope the continue to sell them because the airfit F30 is the best mask that I have used.
RE: Mask recall? - Deborah K. - 01-28-2024
Nothing dental is affected by magnets. No need to worry about that.