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 patient alleges "burning smell coming from the device.Patient is experiencing headache, coughing and nose burning, irritation and congestion.Burning/smoke/electrical odor ".There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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