AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE FLOAT SWITCH ON THE STEAM GENERATOR WAS DAMAGED. AS THE FLOAT SWITCH WAS DAMAGED, THE SWITCH COULD NOT DETECT THAT THE WATER LEVEL IN THE STEAM GENERATOR WAS FILLED, ALLOWING THE GENERATOR TO OVERFILL WITH WATER, CAUSING THE REPORTED EVENT. THE TECHNICIAN REPLACED THE FLOAT SWITCH, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE FLOAT SWITCH IS BEING RETURNED FOR EVALUATION AND A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

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

Additional Manufacturer Narrative

THE FLOAT SWITCH WAS RETURNED TO THE SUPPLIER FOR EVALUATION AND FOUND THAT THE FLOAT SWITCH HAD CRACKED AND WATER WAS OBSERVED INSIDE THE FLOAT SWITCH. THE EXACT CAUSE OF THE DAMAGE TO THE FLOAT SWITCH COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.