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PHS has been informed of an update to the warnings related to the use of the following Philips Respironics Masks:

  • Amara View Minimal Contact Full-Face Mask
  • DreamWear Full Face Mask
  • DreamWisp Nasal Mask with Over the Nose Cushion
  • Wisp Nasal Masks and Wisp Youth Nasal Masks*
  • Therapy Mask 3100 NC/SP

*The magnets in the Wisp Nasal and Wisp Nasal Youth masks can be removed without compromising the effectiveness of the mask. Contact PHS if you need help in this process.

Contraindicated Devices

These masks should not be used by patients and caregivers that have implanted devices that may be affected by magnets. The magnets may cause the implanted devices to not perform as intended, which could lead to serious injury. These devices may include, but are not limited to:

  • Pacemakers
  • Implantable cardioverter defibrillators (ICD)
  • Neurostimulators
  • Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e. neck and head)
  • CSF (cerebral spinal fluid) shunts (e.g., VP (ventriculo peritoneal) shunt)
  • Aneurysm clips
  • Embolic coils
  • Intracranial aneurysm intravascular flow disruption devices
  • Metallic cranial plates, screws, burr hole covers, and bone substitute devices
  • Metallic splinters in the eye
  • Ocular implants (e.g., glaucoma implants, 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)
  • Magnetic denture attachments
  • Metallic gastrointestinal clips
  • Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
  • Implantable ports and pumps (e.g., insulin pumps)
  • Hypoglossal Nerve Stimulators
  • Devices labeled as MR (magnetic resonance) unsafe
  • Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

 

Next Steps for Patients:

Discontinue the use of the mask if your child or any caregivers have any of the devices listed above, and contact PHS  to be fitted for a new mask.