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 (mw5106951).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged short of breath, cough, nasal congestion and fel almost passed out, difficulty breathing at night, sensitive response to different smells that cause him to wheeze.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|