Magnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individuals

Issue

Certain Philips Respironics sleep therapy masks used with Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (BiPAP) machines have magnets in their headgear clips or straps. These magnets could cause safety concerns for people who may be vulnerable to magnetic fields. The sleep therapy mask magnets are used to attach the headgear clips or straps to the mask. Their magnetic field can potentially affect their function or displace some metallic medical devices or objects (e.g., pacemakers, metallic stents, metal in the eye) which may result in serious injury. Philips Respironics is adding a contraindication and is updating product warnings and instructions for use (IFU) to help prevent injury to patients and those close to them, who may be vulnerable to magnetic fields. Philips Respironics has received international reports of potential magnet interference with patient medical devices. These reports include: pacemaker alarms and interference, arrhythmia (irregular heart beat), pacemaker failure leading to replacement, need for shunt adjustment, resetting of automatic implantable cardioverter defibrillator, seizures, defibrillator shutting off periodically and cognitive issues. To date, no incidents have been reported in Canada. Health Canada is advising patients that the affected masks should not be used by patients if they or a person in close proximity to them including, household members, caregivers, or bed partners have any of the implanted metallic medical devices or objects listed below inside their bodies. For patients who have other metallic medical devices or objects inside their bodies that are not included on the list below but that may be affected by magnets, the manufacturer warns that the affected masks should be kept at least 6 inches (approximately 15 cm) away from the device/object. Please note this issue is not related to the recall of Philips Respironics CPAP and BiLevel PAP machines and mechanical ventilators due to issues involving the sound abatement foam, which Health Canada first communicated about in June 2021 and provided an update to in July 2022.

What you should do

• Pacemakers
• Implantable cardioverter defibrillators (ICD)
• Neurostimulators
• Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (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 labelled as MR (magnetic resonance) unsafe
• Magnetic metallic implants not labelled for MR or not evaluated for safety in a magnetic field