AMSCO

Additional Manufacturer Narrative

THROUGH FOLLOW UP WITH THE USER FACILITY, IT WAS DISCOVERED THAT THE NIGHT PRIOR TO THE REPORTED EVENT, USER FACILITY PERSONNEL DID NOT REOPEN THE WATER SUPPLY VALVE AFTER REPLACING INLET FILTERS RESULTING IN THE REPORTED EVENT. THE AMSCO 400 STERILIZER OPERATOR MANUAL STATES, "WATER SUPPLY VALVE - ENSURE THIS IS IN THE OPEN POSITION BEFORE TRYING TO OPERATE THE STERILIZER." ADDITIONALLY, THE 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 STERILIZER SUBJECT OF THE REPORTED EVENT IS OUT OF SERVICE AND PENDING INSPECTION BY A STERIS SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 HAD REDNESS ON THEIR FACE FROM STEAM AFTER OPENING THE DOOR OF THEIR AMSCO 400 STERILIZER. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.

Additional Manufacturer Narrative

TO RESOLVE THE ISSUE, THE TECHNICIAN OPENED THE WATER SUPPLY VALVES. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE AMSCO 400 STERILIZER, SPECIFICALLY ON REOPENING THE VALVES OF THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.