AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN COLLECTED WATER SAMPLES TO BE TESTED. THE RESULTS IDENTIFIED THAT FIVE OF THE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WERE ABOVE THE MAXIMUM REQUIREMENTS FOR THE ELECTRIC STEAM GENERATOR AS STATED IN THE AMSCO C STERILIZER OPERATOR MANUAL (TABLE 7-3. REQUIRED FEED WATER QUALITY FOR CARBON STEEL GENERATORS). THE USER FACILITY IS RESPONSIBLE FOR ENSURING THAT THEIR INCOMING WATER SUPPLY REMAINS WITHIN THE ELECTRIC STEAM GENERATOR'S OPERATING REQUIREMENTS. THE AMSCO C STERILIZER OPERATOR MANUAL STATES (3-1), "WATER QUALITY - SUPPLIED MUST BE WITHIN SPECIFICATIONS. IMPROPER WATER QUALITY ADVERSELY AFFECTS EQUIPMENT OPERATION." THE TECHNICIAN NOTIFIED THE CUSTOMER OF THE WATER QUALITY TEST RESULTS AND THAT THEIR WATER QUALITY IS NOT MEETING THE REQUIRED OPERATING CONDITIONS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO C STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE VIEWPORT WAS DAMAGED ALLOWING WATER TO LEAK FROM THE STERILIZER. THE TECHNICIAN REPLACED THE VIEWPORT, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.