MEDIUM CENTURY STEAM STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE GROMMET OF THE PRESSURE REGULATOR VALVE WAS MISSING. THIS CAUSED THE "TOO LONG TO EVACUATE" ALARM TO DISPLAY AND WHEN THE EMPLOYEE OPENED THE DOOR, STEAM EMITTED FROM THE MACHINE SUBSEQUENTLY CAUSING THE REPORTED EVENT. IT IS UNKNOWN HOW THE GROMMET WAS DISPLACED. TO RESOLVE THE ISSUE, THE TECHNICIAN REBUILT THE PRESSURE REGULATOR VALVE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. THE STERILIZER IS NOT UNDER A STERIS SERVICE CONTRACT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE STERILIZER WAS INSTALLED IN 2006 MAKING IT APPROXIMATELY 19 YEARS OLD. THE MEDIUM CENTURY STERILIZER OPERATOR MANUAL (PG. 5.6) STATES, "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." 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. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HAND AFTER OPENING THE DOOR TO THEIR MEDIUM CENTURY STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.