AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND REVIEWED THE UNIT'S CYCLE PRINTOUT. THE CYCLE PRINTOUT IDENTIFIED THAT THE STERILIZER HAD DISPLAYED A PRESSURE ALARM AND A DOOR UNSEAL ALARM. THE ALARMS ARE INDICATIVE THAT THE FACILITY'S STEAM PRESSURE WAS TOO LOW. ADDITIONALLY, THE CYCLE PRINTOUT SHOWED THAT THE UNIT WAS PLACED INTO SERVICE MODE DURING THE TIME OF THE REPORTED EVENT. BASED ON THE CYCLE PRINTOUT AND TECHNICIAN'S INSPECTION, IT IS LIKELY THAT FOLLOWING THE ALARMS, THE CYCLE ABORTED. USER FACILITY PERSONNEL THEN PLACED THE UNIT INTO SERVICE MODE TO OPEN THE STERILIZER DOOR RESULTING IN THE REPORTED EVENT. THE USER FACILITY SHOULD NOT HAVE PLACED THE UNIT INTO SERVICE MODE BUT RATHER FOLLOWED THE INSTRUCTIONS AS PER THE OPERATOR MANUAL. THE AMSCO 600 STERILIZER OPERATOR MANUAL STATES (PG. 90), "SILENCE ALARM, REQUEST MAINTENANCE TO VERIFY STEAM PRESSURE IS 50 - 80 PSIG, AND CONTACT STERIS". TO RESOLVE THE ISSUE, THE TECHNICIAN PROACTIVELY CALIBRATED THE UNIT. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE AMSCO 600 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER LEAKED WATER ONTO THE FLOOR. NO REPORT OF INJURY.