SMALL CENTURY STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN INSPECTED THE SMALL CENTURY STERILIZER AND FOUND THAT THE HEATING ELEMENT ON THE UNIT WAS DAMAGED WHICH CAUSED SMOKE TO EMIT FROM THE UNIT. THE ROOT CAUSE OF THE REPORTED EVENT IS FROM THE WATER SENSOR OF THE HEATING ELEMENT FAILED WHICH SENT A FALSE SIGNAL CAUSING SMOKE TO EMIT FROM THE UNIT. THE TECHNICIAN REPLACED THE HEATING ELEMENT. WHILE TESTING THE UNIT, THE TECHNICIAN FOUND THAT ONE OF THE GENERATOR CONTACTORS WAS DAMAGED AND REPLACED THE CONTACTOR. THE TECHNICIAN TESTED THE UNIT, FOUND IT TO BE OPERATING TO SPECIFICATIONS AND RETURNED IT BACK TO SERVICE. THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THEIR SMALL CENTURY STERILIZER. NO REPORT OF INJURY OR PROCEDURE DELAY.