inforMED
MalfunctionFLE

GETINGE

Received Apr 9, 2026 · Event occurred Apr 7, 2026

Report MW5186636 · MDR key 24835283

Device

Generic name

Sterilizer, Steam

Manufacturer

Maquet Gmbh

Catalog number

CRN 8034.7C

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

INSTALLING NEW IMMEDIATE USE STEAM STERILIZERS/(IUSS(IMMEDIATE USE STEAM STERILIZATION)) IN THE OPERATING ROOM - NEW DEVICES HAVE AN ENCLOSED STEAM CHAMBER BUT THERE IS NO LID ON THE TOP OF THE DEVICE TO PREVENT ENVIRONMENTAL DUST/DEBRIS BUILDUP ON THE INTERNAL COMPONENTS AND NO RECOMMENDED CADENCE OR DIRECTIONS FOR CLEANING THE IUSS. AFTER INSTALLATION - "NOTED THAT REPORTEDLY A LID CAN BE ORDERED SEPARATELY BUT IS NOT REQUIRED?"