CENTURY STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED THAT TWO EMPLOYEES OPENED THE DOOR TO THEIR 16" CENTURY STERILIZER AND OBTAINED A BURN ON THEIR HANDS FROM A HOT WATER DRIP THAT EMITTED FROM THE CHAMBER OF THE UNIT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THAT THE UNIT'S HEAT EXCHANGER WAS FAILING CAUSING EXCESS VAPOR TO REMAIN IN THE CHAMBER OF THE UNIT. WITHOUT A FUNCTIONAL HEAT EXCHANGER, WATER IS NOT BEING PROPERLY EMPTIED FROM THE UNIT. THE EXCESS WATER THEN CAUSES VAPOR TO CONDENSE ON THE OPENING OF THE CHAMBER FRAME. THE CENTURY STERILIZER OPERATOR MANUAL STATES (PG. 6-3), "WARNING - BURN HAZARD: STEAM MAY BE RELEASED FROM THE CHAMBER WHEN DOOR IS OPENED. STEP BACK FROM THE STERILIZER EACH TIME THE DOOR IS OPENED TO MINIMIZE CONTACT WITH STEAM VAPOR." THE TECHNICIAN REPLACED THE HEAT EXCHANGER. A TEST CYCLE WAS PERFORMED, THE UNIT WAS CONFIRMED OPERATIONAL AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

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.