Description of Event or Problem · 1
A 79 YEAR OLD FEMALE PATIENT WAS TRANSPORTED TO ENDOSCOPY AT 0726 MARCH 7, 1994 FOR A BRONCHOSCOPY. DURING THE PROCEDURE THE PHYSICIAN INTUBATED THE PATIENT USING THE BRONCHOSCOPE AND A ENDOTRACHEAL TUBE. THE BRONCHOSCOPE WAS REMOVED AND A SWIVEL OXYGEN ADAPTER WAS CONNECTED AND TAPED. THE WHITE MEMBRANE OF THE ADAPTER REMAINED IN PLACE. THE BRONCHOSCOPE WAS THEN REINSERTED. OXYGEN SATURATION DECREASED TO 84$, AND THE PHYSICIAN GAVE ORDERS TO INCREASE THE OXYGEN FLOW RATE TO 15 1/MIN. APPROXIMATELY 30-60 SECONDS LATER, FACIAL EDEMA, ABDOMINAL DISTENSION, AND NECK DISTENSION WERE NOTED. THE PHYSICIAN EXTUBATED THE PATIENT, POSITIONED HER ON THE RIGHT SIDE AND MAINTAINED THE AIRWAY. A CODE WAS CALLED. THE PATIENT WAS REINTUBATED AND CARDIOPULMONARY RESUSCITATION WAS IN PROGRESS. A CHEST X-RAY WAS TAKEN WHICH INDICATED BILATERAL PNEUMOTHORACES. A RIGHT AND LEFT CHEST TUBE WERE INSERTED AND CARDIOPULMONARY RESUSCITATION CONTINUED. HOWEVER, THE PATIENT DID NOT RESPOND TO AGGRESSIVE MEDICAL TREATMENT AND EXPIRED AT 0836.(PLEASE REFERENCE 450056-1994-002 AND 450056-1994-007THERE WAS ONLY ONE DEATH BUT MULTIPLE DEVICES USED.)DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-94. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.