AMSCO 400 STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS EMITTING STEAM AND SMOKE. NO REPORT OF INJURY.

Additional Manufacturer Narrative

CONTRARY TO THE REPORTED EVENT, A STERIS SERVICE TECHNICIAN RECEIVED CONFIRMATION THAT SMOKE WAS NOT EMITTING FROM THE AMSCO 400 STERILIZER AND THAT ONLY STEAM WAS. THE STERIS SERVICE TECHNICIAN STATED THAT THE STEAM ALLOWED CONDENSATION (WATER) TO ACCUMULATE ON THE FLOOR. THE STERIS TECHNICIAN INSPECTED THE AMSCO 400 AND FOUND THAT THE HEATING ELEMENT HAD SHORTED. THE SAFETY VALVE OPERATED PROPERLY AND RELEASED STEAM FROM THE STERILIZER CAUSING THE REPORTED EVENT. THE STERIS TECHNICIAN MADE REPAIRS TO THE AMSCO 400, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING PROPERLY. THE AMSCO 400 WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

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.