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 voluntary medwatch (mw5111993) alleging an issue related to a continuous positive airway pressure (cpap) device.The manufacturer received information alleging that the right side went completely numb, had palpitation, went to er and had seizure and was prescribed medication, and was diagnosed with heart failure/ thickening of the heart muscle.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 received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleging that the right side went completely numb, had palpitation, went to er and had seizure and was prescribed medication, and was diagnosed with heart failure/ thickening of the heart muscle.There was no medical intervention required by the patient.The reported event of alleging that the right side went completely numb, had palpitation, went to er and had seizure and was prescribed medication, and was diagnosed with heart failure/ thickening of the heart muscle and 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.The patient has swapped out the deice at the distributor and at this time, 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.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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