inforMED
MalfunctionFLE

AMSCO

Received Nov 27, 2024 · Event occurred Oct 28, 2024

Report 3005899764-2024-00068 · MDR key 20795503

Device

Generic name

Amsco 600 Steam Sterilizer

Catalog number

EF130114200102

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 INSPECTED THE AMSCO 600 STEAM STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE UNIT; THE REPORTED EVENT COULD NOT BE DUPLICATED. THE TECHNICIAN RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT UPON OPENING THE DOOR OF THEIR AMSCO 600 STEAM STERILIZER, WATER LEAKED ONTO THE FLOOR. NO REPORT OF INJURY.