The manufacturer received information that an end user allegedly received the wisp mask with magnetic connections and was concerned because she has a pacemaker/defibrillator and was worried the magnetic clips would affect her heart.The user was instructed to keep the mask 6-8 inches from her heart and to also speak with her doctor.The user is concerned when turning in her sleep she might cause herself harm.There was no report of medical intervention.There was no report of patient harm or injury.No product will be returned for investigation.The wisp instructions for use includes the following warnings: the headgear clips contain magnets.Contact your healthcare professional before you use this mask.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 2 in.(50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators, and cochlear implants.Do not use in or near magnetic resonance imaging (mri) equipment.Keep unassembled magnetic headgear clips out of reach of children.In case of accidental swallowing, seek medical assistance immediately.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.
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