BOEHRINGER LOCKING CABLE

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED BY BOEHRINGER LABORATORIES (MANUFACTURER) IN ORDER TO PROVIDE INFORMATION NOT INCLUDED (MODEL, LOT # ETC.) ON USER FACILITY REPORT (B)(4) (COPY INCLUDED). A PATIENT OWNED, ELECTRONIC SERVICE WAS BEING PLUGGED INTO A WALL OUTLET IN A HOSPITAL ROOM. A SUCTION REGULATOR TETHER WAS INADVERTENTLY CAUGHT BY THE ELECTRICAL PLUG, RESULTING IN A SPARK. THERE WAS NO DEATH, INJURY OR DEVICE MALFUNCTION. NEITHER THE TETHER NOR THE SUCTION REGULATOR WERE DAMAGED. THE USER FACILITY HAS DECIDED USING THE SUCTION REGULATOR TETHER MODEL 9143 AND HAS HAD OUR REPRESENTATIVE REMOVE THEM FROM THEIR SUCTION REGULATORS. THE USER FACILITY HAS STATED THAT THEY BELIEVE THE SUCTION REGULATOR TETHERS DO NOT CONFORM TO THE NFPA (B)(4): HEALTH CARE FACILITIES CODE. BOEHRINGER LABORATORIES HAS BEEN IN COMMUNICATION WITH THE USER FACILITY REGARDING THE ABOVE AND HAS REVIEWED THE NFPA (B)(4) CODE. WHILE BOEHRINGER LABORATORIES RESPECTS THE OPINION OF THE USER FACILITY/CUSTOMER, WE DO NOT FIND THAT THE MODEL 9143 TETHER VIOLATES NFPA (B)(4). SINCE THERE WAS NO DEATH, INJURY OR MALFUNCTION, THIS VOLUNTARY FORM IS BEING USED IN LIEU OF A MANDATORY REPORT, AS PROVIDED FOR IN SECTION OF THE FORM INSTRUCTIONS FOR FDA 3500A. REF UF REPORT # (B)(4).