Description of Event or Problem · 1
C.N.A. WAS LOWERING RESIDENT WITH S.A.R.A. LIFT AND CRANK (HANDLE) SWUNG AND HIT C.N.A.'S ELBOW. THIS TRANSFERRING DEVICE HAS A LARGE HANDLE WITH THREE HAND GRIPS, ONE WAS MISSING AND HAD BEEN ORDERED PRIOR TO INCIDENT, TO DRIVE THE SLING TYPE LIFTING MECHANISM. PROPER INSTRUCTION AND PROCEDURE TO TURN HANDLE SLOWLY WERE NOT IMPLEMENTED FACILITATING HANDLE SWINGING AND INJURY UPON EVALUATION. PHYSCIAN ORDERED NO LIFTING FOR 48 HOURS DUE TO LEFT (L) ELBOW BRUSING AND SWELLING FOR C.N.A. UPON EXAMINATIONDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-91. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.