inforMED
MalfunctionFLE

AMSCO EVOLUTION

Received Feb 13, 2025 · Event occurred Jan 16, 2025

Report 3005899764-2025-00016 · MDR key 21379078

Device

Generic name

Medium Evolution Sterilizer

Model number

HC-1500

Catalog number

UE03

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED A STEAM LEAK FROM THEIR MEDIUM EVOLUTION STERILIZER. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE MEDIUM EVOLUTION STERILIZER AND FOUND THAT THE STEM COMPONENT TO THE PRESSURE REGULATOR VALVE WAS DAMAGED, ALLOWING STEAM TO RELEASE FROM THE UNIT. THE MEDIUM EVOLUTION STERILIZER IS NOT UNDER A STERIS SERVICE CONTRACT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN REBUILT THE PRESSURE REGULATOR VALVE, TESTED THE UNIT, CONFIRMED IT BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.