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 previously received information alleging shortness of beath, pulmonary hypertension and cough related to a cpap device's sound abatement foam.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.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.Placed call to customer requesting device return/ mandatory questions / underlying health conditions / additional information regarding particles issue.Left message on voicemail.A2, a3, d4 sections were corrected and health effect - clinical code is coded (pulmonary hypertention) in this fallow up, section h6 updated in this report.
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