MEDIUM CENTURY STEAM STERILIZER

Additional Manufacturer Narrative

A THIRD-PARTY SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE MEDIUM CENTURY STEAM STERILIZER AND FOUND THE HEAT EXCHANGER WAS CLOGGED WHICH RESULTED IN THE REPORTED LEAK. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE STERILIZER, CONFIRMED IT TO BE OPERATIONAL, AND RETURNED IT TO SERVICE. THE MEDIUM CENTURY STEAM STERILIZER OPERATOR MANUAL STATES (1-2), "WARNING-PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: REGULARLY SCHEDULED PREVENTIVE MAINTENANCE IS REQUIRED FOR SAFE AND RELIABLE OPERATION OF THIS EQUIPMENT. CONTACT YOUR STERIS SERVICE REPRESENTATIVE TO SCHEDULE PREVENTIVE MAINTENANCE. REPAIRS AND ADJUSTMENTS TO THIS EQUIPMENT MUST BE MADE ONLY BY FULLY QUALIFIED SERVICE PERSONNEL. MAINTENANCE PERFORMED BY INEXPERIENCED, UNQUALIFIED PERSONS OR INSTALLATION OF UNAUTHORIZED PARTS COULD CAUSE PERSONAL INJURY OR RESULT IN COSTLY EQUIPMENT DAMAGE." THE MEDIUM CENTURY STEAM STERILIZER WAS INSTALLED IN 2007 AND IS NOT UNDER A STERIS SERVICE CONTRACT FOR MAINTENANCE; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR MEDIUM CENTURY STEAM STERILIZER ALARMED TOO LONG IN EXHAUST DURING A CYCLE. IT HAS BEEN REPORTED THAT THERE WAS A WATER LEAK, AND AT THIS TIME IT IS UNKNOWN THE SIZE OF THE LEAK. NO REPORT OF INJURY.