The manufacturer received information alleging an oxygen concentrator was provided to the patient without the device instructions of use.The patient expired.The device is not life supporting or life sustaining.Repeated attempts to have the 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.
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