Description of Event or Problem · 1
STAFF NURSE WAS INJURED DURING DAILY ROUTINE INSPECTION OF EMERGENCY ROOM DEFIBRILLATOR. NURSE CHARGED THE UNIT TO 200 JOULES AND THEN DISCHARGED THE DEFIB WITH PADDLES INSIDE THE TEST WELLS. SHE RECEIVED A JOLT. THE POINT OF ORIGIN WAS HER LEFT THUMB. THE ENERGY TRAVELED FROM LEFT HAND TO RIGHT HAND, TERMINATING IN THE RIGHT THUMB. THE NURSE RECEIVED A MINOR BURN TO THE LEFT THUMB. NO OTHER COMPLICATIONS OR INJURIES NOTED. EXAMINATION OF THE DEVICE REVEALED NO INSTRUMENT MALFUNCTION OR BREAKDOWN IN THE INSULATION OF THE PADDLES OR DEVICE. THE OPERATOR MANUAL CLEARLY DEMONSTRATES THE CORRECT HAND PLACEMENT FOR DISCHARGING THE DEVICE. THE CAUTION ON THE DEVICE EXPLAINS TO THE OPERATOR TO KEEP HANDS CLEAR OF THE PADDLE ELECTRODE SURFACE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-95. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF, INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.