ResMed FDA Class 1 Mask Recall is VERY SERIOUS!

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  • čas přidán 24. 07. 2024
  • FDA Recall Information:
    www.fda.gov/medical-devices/m...
    File a Complaint:
    www.fda.gov/consumers/consume...

Komentáře • 7

  • @USAMedicalSupply
    @USAMedicalSupply  Před 5 měsíci

    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.

  • @dwaynewood1795
    @dwaynewood1795 Před 6 měsíci +4

    Thank you for sharing, I will let my fellow CPAP users know. Therapy going great 7 year nightly survivor (lol) Love the therapy, best life changing health improvement.

  • @Lost-In-Blank
    @Lost-In-Blank Před 6 měsíci +2

    Thank you for this. Good advice. I have a P20 and P30i mask, but no implanted medical device, so I can now relax.

  • @jonhansen4745
    @jonhansen4745 Před 6 měsíci +2

    I had a pacemaker implanted on Nov.16, 2023 & came home the next day. That afternoon I was on YT and saw a warning about these masks & the possibility of the magnets interrupting the pacemaker. I've worn an F30i mask and others with the magnetic clasps for the past 5 years or so. I called my local medical supply house and they have been aware of the issue for more than a year. I was told they always recommend a non magnetic mask for anyone that they are aware of who has a pacemaker. They had me come down that afternoon & had me try an N30i to see how it would work for me and after a few nights of dealing with a poor mask seal, I went back and picked up a P30i mask. It's by far the best mask I've used since starting with BiPap. And no magnets.

    • @USAMedicalSupply
      @USAMedicalSupply  Před 6 měsíci +1

      Thanks for sharing and all the best in your PAP Journey!

  • @fixitfelix718
    @fixitfelix718 Před 5 měsíci

    Recall is jussst for implanted devices????? Not like the Phillips toxic gas or foam issues?

    • @USAMedicalSupply
      @USAMedicalSupply  Před 5 měsíci

      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.