inforMED
MalfunctionFLE

GETINGE STEAM STERILIZER

Received Apr 15, 2025 · Event occurred Feb 21, 2025

Report 21840138 · MDR key 21840138

Device

Generic name

Sterilizer, Steam

Manufacturer

Maquet Gmbh

Product problems

  • Defective Device
  • Detachment of Device or Device Component
  • Device Fell

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

NO PATIENT HARM NOR ANY PATIENT INVOLVEMENT. NO STAFF HARM. THE CART WASHER FINISHED ITS CLEANING CYCLE, AND THE TECH WENT OVER TO OPEN THE DOOR AND PULL THE CART OUT. AS THE DOOR WAS OPENING, A BOLT FELL OUT AND THE DOOR CAME OFF TRACK AND FELL TO THE GROUND TILTED ON ITS SIDE. NO ONE WAS INJURED. A BIOMEDICAL ENGINEERING WORK ORDER WAS PLACED, AND THE EQUIPMENT WAS REMOVED FROM SERVICE/USAGE AT THE TIME OF INCIDENT. THE MANUFACTURER WAS CONTACTED DIRECTLY AND CAME ONSITE TO CONDUCT THE DEVICE REPAIR. THE DEVICE IS NOW OPERATIONAL AND IS BACK IN SERVICE.