inforMED
MalfunctionFLE

AMSCO 600 STERILIZER

Received Sep 13, 2023 · Event occurred Aug 21, 2023

Report 3005899764-2023-00045 · MDR key 17738631

Device

Generic name

Sterilizer

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

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 THE SIGHT GLASS UPPER SEAL WAS DAMAGED ALLOWING WATER TO LEAK FROM THE STERILIZER. THE TECHNICIAN REPLACED THE SIGHT GLASS AND SEAL, TESTED THE UNIT, CONFIRMED THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATION, AND THE UNIT WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

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