AMSCO

Additional Manufacturer Narrative

THE WATER SUPPLY TO THE AMSCO 400 STERILIZER SHOULD BE TURNED OFF WHILE THE UNIT IS OUT OF SERVICE PENDING REPAIRS. HOWEVER, THE USER FACILITY INDICATED THAT THE WATER SUPPLY WAS ON AT THE TIME OF THE REPORTED EVENT. BASED ON THE INVESTIGATION, STERIS WAS UNABLE TO DETERMINE WHETHER THE TECHNICIAN HAD FAILED TO SHUT OFF THE WATER SUPPLY OR IF USER FACILITY PERSONNEL TURNED IT BACK ON PRIOR TO REPAIRS BEING COMPLETED. FOLLOWING THE REPORTED EVENT, THE USER FACILITY TURNED OFF THE WATER SUPPLY AND CLEANED UP THE LEAK. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND WAS UNABLE TO DUPLICATE THE REPORTED LEAK. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE THEIR AMSCO 400 STERILIZER WAS OUT OF SERVICE PENDING REPAIRS, THE UNIT LEAKED WATER. NO REPORT OF INJURY.