AMSCO 400 STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER. THE TECHNICIAN FOUND A BOLT BROKE ON THE CK5 CHECK VALVE CAUSING WATER TO LEAK FROM THE UNIT. FURTHER INSPECTION OF THE STERILIZER FOUND WATER DAMAGE TO THE COMPONENTS INSIDE THE GENERATOR CONTROL BOX. PARTS HAVE BEEN ORDERED TO COMPLETE THE REPAIRS AND THE UNIT IS CURRENTLY OUT OF SERVICE PENDING REPAIRS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE REPAIRS HAVE BEEN COMPLETED. 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 THEIR AMSCO 400 STERILIZER LEAKED WATER ONTO THE FLOOR. NO REPORT OF INJURY.