AMSCO 600

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IT SHOULD BE NOTED THAT THIS SPECIFIC MODEL IS NOT SOLD IN THE UNITED STATES, SO IT IS NOT IN GUDID.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN ALARM OCCURRED, AND THE CYCLE ABORTED WHILE PROCESSING INSTRUMENTS IN THEIR AMSCO 600 STERILIZER. THE INSTRUMENTS WERE REPACKED AND REPROCESSED IN ANOTHER UNIT RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE USER FACILITY REPORTED THREE STERILIZERS SUBJECT OF THE REPORTED EVENT: (B)(6). FOLLOWING THE REPORTED EVENT, A STERIS ACCOUNT MANAGER LEARNED THE LOADS WERE INSIDE THE UNITS LONGER THAN EXPECTED DUE TO CONNECTIVITY ERROR ALARMS THAT PAUSED THE CYCLES, ATTRIBUTING TO PROCEDURE DELAYS. THE USER FACILITY'S THIRD-PARTY SERVICE PROVIDER ARRIVED ONSITE TO INSPECT THE AMSCO 600 STERILIZER SUBJECT OF THE REPORTED EVENT AND CONFIRMED THE HMI CABLE AND CONTROLLER CABLE WERE DISCONNECTED. THE SERVICE PROVIDER RECONNECTED THE CABLES, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. THE AMSCO 600 STERILIZER OPERATOR MANUAL STATES, "TROUBLESHOOTING - CONNECTION ISSUE; HAVE BIOMED VERIFY THE CONNECTIONS TO THE DISPLAY OR CONTACT STERIS." A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.