CENTURY MODEL

Description of Event or Problem

DURING EMERGENCY TRANSFER OF PATIENT FROM MICU TO RADIOLOGY, A SHOCK ABSORBER WAS DISCOVERED HANGING DOWN FROM THE PATIENT'S RIGHT SIDE OF THE BED (HEAD SECTION). THE EMERGENCY TRANSFER AND CT SCAN WAS DELAYED BY THE NEED TO TRANSFER THE PATIENT TO A BED IN OPERTING CONDITION. THE SHOCK ABSORBER WAS DISCOVERED TO BE HANGING DOWN WITH A BROKEN POST STILL CONNECTEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INADEQUATE QUALITY ASSURANCE, FAILURE TO SERVICE/MAINTAIN ACCORDING TO MANUFACTURER RECOMM. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.