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.Patient alleged of waking up at night with arrhythmia and had cardiac ejection fraction dropping down to 7 points; has difficulty breathing/shortness of breath.Patient was advised by his pulmonologist and cardiac physician to use a bipap.Patient also stated that device has strange odor, burning/smoke/electrical odor.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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