The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, and mechanical ventilator devices.The manufacturer received information alleging dry eyes, swallowing issue, throat swelling.Bronchitis, severe chronic fatigue, lyme disease, trouble breathing and shortness of breath, sickness from aspergillus, nasal/throat irritation or soreness.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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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 previously received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to experience dry eyes, swallowing issue, throat swelling.Bronchitis, severe chronic fatigue, lyme disease, trouble breathing and shortness of breath, sickness from aspergillus, nasal/throat irritation or soreness.There was no medical intervention required by the patient.The reported event of dry eyes, swallowing issue, throat swelling.Bronchitis, severe chronic fatigue, lyme disease, trouble breathing and shortness of breath, sickness from aspergillus, nasal/throat irritation or soreness and its reported severity was reviewed by the manufacturer's clinical expert.This event is assessed as not related to the device in this case.Based on the information available, the manufacturer concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation.The patient has swapped out the device at the distributer and at this time no further investigation can be performed.If any additional information is received, a follow-up report will be filled.Section 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.Section h6 health effect-impact code, type of investigation, investigation findings and investigation conclusions have been updated.
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