REMANUFACTURED EAGLE 3000 STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED THAT WATER AND STEAM WAS LEAKING FROM THEIR REMANUFACTURED EAGLE 3000 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT WATER AND STEAM WAS LEAKING FROM THE STEAM GENERATOR. STEAM WAS ALSO LEAKING FROM THE SAFETY VALVE INDICATING THAT THE GENERATOR HAD OVER PRESSURIZED. THE TECHNICIAN ALSO FOUND THAT THE CONTACTOR WAS STUCK IN THE CLOSED POSITION WHICH CAUSED THE GENERATOR TO OVER PRESSURIZE AND OVERHEAT. AS A RESULT OF THE OVERHEATING, THE HEATING ELEMENT WITHIN THE GENERATOR BECAME DAMAGED. THE TECHNICIAN ALSO FOUND THAT THE GENERATOR HAD A SIGNIFICANT AMOUNT OF SCALE BUILD UP DUE TO THE WATER QUALITY. IN ADDITION, THE DRAIN BELOW THE UNIT WAS BACKED UP SO THE STEAM AND WATER COULD NOT PROPERLY FLOW DOWN THE DRAIN. THE USER FACILITY STATED THAT THEY ARE WORKING TO MAKE IMPROVEMENTS TO THEIR WATER QUALITY. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THIS UNIT WAS MANUFACTURED IN 2003 AND WAS APPROXIMATELY 20 YEARS OLD AT THE TIME OF THE REPORTED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.