48" PLATFORM PREVAC STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN INSPECTED THE 48" PLATFORM PREVAC STERILIZER AND FOUND THAT THE UNIT'S DRAIN AREA WAS FILLED WITH WATER AND WAS CONTINUOUSLY FILLING. THE TECHNICIAN ISOLATED POTENTIAL WATER SOURCES AND FOUND THAT THE CK8 VALVE WAS LEAKING WATER. PRIOR TO THE REPORTED EVENT, THE STERILIZER WAS INACTIVE FOR SEVERAL HOURS. THE WATER COLLECTING IN THE DRAIN AREA HAD TURNED INTO STEAM, CAUSING THE REPORTED EVENT TO OCCUR. THE TECHNICIAN REPLACED THE CK8 VALVE, RAN A TEST CYCLE, CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. 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.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OPENED THEIR 48" PLATFORM PREVAC STERILIZER DOOR AND ENCOUNTERED STEAM, SUBSEQUENTLY CAUSING A BURN TO THE EMPLOYEE'S NOSE. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.