AMSCO

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

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

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE AMSCO 600 STERILIZER. THE TECHNICIAN FOUND THAT THE SAFETY VALVE WAS NOT OPERATING PROPERLY SUBSEQUENTLY CAUSING THE REPORTED EVENT. THE SAFETY VALVE WAS RETURNED TO THE SUPPLIER FOR EVALUATION AND FOUND THAT ONE OF THE INTERNAL COMPONENTS OF THE SAFETY VALVE WAS MISALIGNED. THE CAUSE OF THE MISALIGNMENT COULD NOT BE DETERMINED. THE TECHNICIAN REPLACED THE SAFETY VALVE, TESTED THE FUNCTION AND OPERATION OF THE STERILIZER AND RETURNED THE DEVICE TO SERVICE. A 3-YEAR COMPLAINT REVIEW CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.