PHILIPS DIAG. CINE EQUIPMENT II SHIELD

Description of Event or Problem

DURING DIAGNOSTIC CARDIAC PROCEDURE, CINE EQUIPMENT FAILED TO DISPLAY VIDEO PICTURES ON THE MONITOR. CO'S REPAIR TECHNICIAN IMMEDIATELY CAME INTO THE ROOM AND ADJUSTMENTS WERE MADE. CINE VIDEO CONTINUED TO BE FAULTY WHERE DR COULD NOT VISUALUZE CINE RUN. PROCEDURE INCOMPLETE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.