3085 SHOULDER TABLE ACCESSORY

Additional Manufacturer Narrative

THE 3085 SHOULDER TABLE ACCESSORY IS APPROXIMATELY 12 YEARS OLD AND IS NOT SERVICED OR MAINTAINED BY STERIS. THE USER FACILITY'S BIOMEDICAL DEPARTMENT PROVIDES SERVICE AND MAINTENANCE TO THE DEVICE. A STERIS SURGICAL SERVICE REPRESENTATIVE INSPECTED THE 3085 SHOULDER TABLE ACCESSORY AND FOUND NO ISSUES WITH THE FUNCTION OR OPERATION. STERIS WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE USER FACILITY'S BIOMEDICAL TECHNICIAN ALSO INSPECTED THE 3085 SHOULDER TABLE ACCESSORY AND WAS NOT ABLE TO DUPLICATE THE REPORTED EVENT. AS NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE DEVICE AND THE REPORTED EVENT COULD NOT BE DUPLICATED, THE EVENT CAN BE ATTRIBUTED TO USER FACILITY PERSONNEL NOT PROPERLY POSITIONING THE 3085 SHOULDER TABLE ACCESSORY WITH THE SURGICAL TABLE. THE LEG SECTION OF THE SURGICAL TABLE MUST BE RAISED SO THAT IT CONTACTS THE SHOULDER TABLE TO SAFELY SUPPORT THE PATIENT'S WEIGHT PRIOR TO LOOSENING THE POSITION LOCK KNOBS ON BOTH SIDES OF THE SHOULDER TABLE. THE OPERATOR MANUAL STATES (PG. 2-1), "WARNING - SAFEGUARD PATIENT- READ AND UNDERSTAND ALL OF THIS MANUAL BEFORE USING THE SHOULDER TABLE. FOLLOW EACH STEP IN THE ORDER PRESENTED IN THESE INSTRUCTIONS. IF YOU NEED TECHNICAL ASSISTANCE OR ADDITIONAL INSTRUCTIONS, CALL STERIS. WARNING - PERSONAL INJURY HAZARD - WHEN POSITIONING THE PATIENT ON THE SHOULDER TABLE, ENSURE THE PATIENT'S HEAD, ARMS, AND TORSO ARE SUPPORTED. - TO ASSURE PATIENT STABILITY, BEFORE ARTICULATING THE SURGICAL TABLE OR THE SHOULDER TABLE, SUPPORT THE PATIENT ON THE TABLE IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICES. WARNING - PATIENT INSTABILITY HAZARD: - TO PREVENT SHOULDER TABLE MOVEMENT, ALWAYS ENSURE THE RAIL LOCK TABS ON BOTH SIDES OF THE SHOULDER TABLE FULLY ENGAGE THE SIDE RAILS OF THE TABLE SEAT SECTION, AND VERIFY THAT THE SHOULDER TABLE CANNOT BE SLIPPED OFF THE SURGICAL TABLE SIDE RAILS. - TO PREVENT SHOULDER TABLE MOVEMENT, ALWAYS ENSURE THE RED INDICATORS ON THE RAIL LOCK KNOBS AND POSITION LOCK KNOBS ON BOTH SIDES OF THE SHOULDER TABLE ARE NOT VISIBLE AND THAT THE ROSETTE TEETH ON BOTH POSITION LOCKS ARE FULLY ENGAGED. - DO NOT RAISE OR LOWER THE PATIENT MANUALLY. ALWAYS USE THE POWERED LEG SECTION TO RAISE OR LOWER THE PATIENT." THE OPERATOR MANUAL FURTHER STATES (SECTION 2.5), "AFTER COMPLETING THE SURGICAL PROCEDURE, TRANSFER THE PATIENT FROM THE TABLE AS FOLLOWS: 1. RAISE THE LEG SECTION OF THE SURGICAL TABLE SO THAT IT CONTACTS THE SHOULDER TABLE, TO SAFELY SUPPORT THE PATIENT'S WEIGHT. 2. WHILE SUPPORTING THE PATIENT'S HEAD, REMOVE THE HEAD RESTRAINT STRAPS AND HEAD REST ASSEMBLIES FROM THE HEAD REST SUPPORT PANEL. 3. WHILE SUPPORTING THE PATIENT'S HEAD, COMPLETELY LOOSEN THE POSITION LOCK KNOBS ON BOTH SIDES OF THE SHOULDER TABLE. 4. WHILE SUPPORTING THE PATIENT'S HEAD, RETURN THE SURGICAL TABLE TO THE LEVEL POSITION. 5. TRANSFER THE PATIENT TO A STRETCHER IN ACCORDANCE WITH RECOMMENDED PATIENT TRANSFER PRACTICES." A WARNING LABEL IS ALSO APPLIED TO THE BACK PANEL OF THE 3085 SHOULDER TABLE ACCESSORY. "WARNING - SAFEGUARD PATIENT: READ AND UNDERSTAND ALL OF THIS MANUAL BEFORE USING THE SHOULDER TABLE. FOLLOW EACH STEP IN THE ORDER PRESENTED IN THE MANUAL. IF YOU NEED TECHNICAL ASSISTANCE OR ADDITIONAL INSTRUCTIONS, CALL STERIS CUSTOMER SERVICE AT 1-800-333-8828. - PATIENT INSTABILITY HAZARD: DO NOT RAISE OR LOWER THE PATIENT MANUALLY. ALWAYS USE THE POWERED LEG SECTION TO RAISE OR LOWER THE PATIENT." "WARNING - INSTABILITY HAZARD: TO PREVENT SHOULDER TABLE MOVEMENT, ALWAYS CHECK TO SEE THAT THE RED INDICATORS ON THE RAIL LOCK KNOBS AND POSITION LOCK KNOBS ON BOTH SIDES OF THE SHOULDER TABLE ARE NOT VISIBLE AND THAT THE ROSETTE TEETH ON BOTH POSITION LOCKS ARE FULLY ENGAGED." A STERIS ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE 3085 SHOULDER TABLE ACCESSORY. THE STERIS SURGICAL SERVICE REPRESENTATIVE RETURNED THE 3085 SHOULDER TABLE TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AT THE CONCLUSION OF A PATIENT PROCEDURE, THE 3085 SHOULDER TABLE ACCESSORY ROTATED IN ORIENTATION SUBSEQUENTLY CAUSING THE PATIENT TO BECOME UNSTABLE AND FALL FROM THE SURGICAL TABLE. THE PATIENT SUSTAINED AN INJURY AND REQUIRED ADDITIONAL MEDICAL TREATMENT.