MEDIUM CENTURY STEAM STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND NO ISSUES WITH THE STERILIZER. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. FOLLOWING THE REPORTED EVENT, THE TECHNICIAN DISCOVERED THAT USER FACILITY PERSONNEL ATTEMPTED TO ABORT A CYCLE. HOWEVER, THE POWER TO THE UNIT WAS SHUT OFF WHICH DID NOT ALLOW THE ABORTED CYCLE PROCESS TO BE FULLY COMPLETED, WHICH INCLUDES REMOVAL OF STEAM FROM THE CHAMBER. THE EMPLOYEE THEN OPENED THE DOOR OF THE STERILIZER, SUBSEQUENTLY CAUSING THE REPORTED EVENT. THE MEDIUM CENTURY STERILIZER OPERATOR MANUAL 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." WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE MEDIUM CENTURY STERILIZER, SPECIFICALLY ON MAINTAINING A SAFE DISTANCE FROM THE STERILIZER WHEN THE DOOR IS OPENED AND ENSURING THAT A CYCLE IS FULLY ABORTED BEFORE OPENING THE DOOR. 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 OBTAINED A STEAM BURN TO THEIR FACE 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.