The manufacturer became aware that a user with an implanted neurostimulator in her back, has noticed that it has not been working as well to reduce her pain.She was using the wisp mask with magnets with her cpap.Her spinal doctor decreased the level of vibrations which has helped temporarily.The user is wondering if it is the mask effecting her implant.The user is removing the magnets and waiting on getting the non-magnetic clips.She is complaining of pain and sleepiness.The mask has not returned for evaluation due to she is now using the clips with her mask.Multiple attempts have been made for additional information and the return of the mask.The manufacturer will continue to monitor complaints for similar issues.If additional information becomes available, a follow up report will be filed.The manufacturer concludes no further action is needed at this time.
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged that she was using the wisp mask with magnets with her cpap, her spinal doctor decreased the level of vibrations which has helped temporarily.The user is wondering if it is the mask effecting her implant.The user is removing the magnets and waiting on getting the non-magnetic clips.She is complaining of pain and sleepiness.There was no medical intervention required by the patient.The reported event of pain, sleepinesand its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.In initial report, section g4, h7 and h9 sections were not captured, corrected and updated in this report.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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