inforMED
MalfunctionFLE

AMSCO 400 STERILIZER

Received Apr 19, 2024 · Event occurred Mar 21, 2024

Report 3005899764-2024-00018 · MDR key 19144894

Device

Generic name

Sterilizer

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND ONE OF THE CONTACTORS STUCK IN THE HEATERS OF THE GENERATOR. AS THE CONTACTOR WAS STUCK IN THE CLOSED POSITION, THIS ALLOWED CONTINUOUS POWER TO BE PROVIDED TO THE UNIT CAUSING EXCESS STEAM TO BUILD UP. AS DESIGNED, THE SAFETY VALVE OPENED, AND EXCESS STEAM EMITTED FROM THE UNIT; NO SMOKE OR FLAMES WERE OBSERVED. THE DEVICE HISTORY RECORD FOR THE UNIT WAS REVIEWED AND CONFIRMED THE UNIT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE TECHNICIAN REPLACED THE CONTACTOR AND NECESSARY COMPONENTS. AFTER THE UNIT WAS TESTED AND CONFIRMED OPERATING ACCORDING TO SPECIFICATIONS IT WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED A BURNING SMELL AND STEAM LEAK FROM THEIR AMSCO 400 STERILIZER. THERE WAS A PROCEDURE DELAY REPORTED AS A RESULT OF THE EVENT. NO REPORT OF INJURY.