AMSCO

Additional Manufacturer Narrative

A STERIS TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE SOLENOID VALVE THAT FEEDS HOT WATER TO THE STEAM GENERATOR FAILED WHICH CAUSED THE WATER LEAK OF THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE SOLENOID VALVE, TESTED THE UNIT, FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT BACK 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 THEIR AMSCO 400 STERILIZER LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.