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 stated that he is coughing more often than normal.Headache, respiratory tract irritation, chest pressure, sinus infection.All of the information he stated that is due to him using his affected device.Unit is scrapped.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's quality product investigation laboratory for further investigation, in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.An internal investigation was performed on the device.The technician confirmed no particles in the air path or no visible foam degradation during the device evaluation.Device not needed for internal stock and will be scrapped per fc:16-700-623.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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