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Patient 1
THEPT WAS SCHEDULED FOR A UGI AND SMALL BOWEL SERIES ON 5/4/95. HE HAD A HISTORY OF REFLUX, COPD, PNEUMONIA, TB-MAI IN 1994. DURING THE UGI HE HAD A SMALL AMOUNT OF COUGHING, BUT DID NOT APPEAR TO HAVE ASPIRATED THE BARIUM. SUBSEQUENT ABDOMINAL FILMS FOR THE SMALL BOWEL SERIES SHOWED THERE WAS A MEDIUM AMOUNT OF BARIUM IN THE BRONCHIAL TREE, LOWER LOBES, APPARENTLY DUE TO ASPIRATION. THE PT WAS MONITORED FOR 2 AND 1/2 HOURS FOLLOWING THE PROCEDURES AND HAD NO DISTRESS OR CHANGE IN VITAL SIGNS. THE PT DEVELOPED PNEUMONIA/ARDS AND SUBSEQUENTLY DIED ON 5/12/95.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.