Events

Recall of Weinmann Medumat Transport Ventilator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01126-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01126-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, weinmann emergency, has identified a potential issue that could result in an undefined operating state of the medumat transport ventilator. in some cases an interaction between internal structural components and sensors for internal device monitoring can cause an undefined operating state resulting in the device displaying a "device malfunction" error.
  • Action
    Maquet is advising users to switch the machine off and on again in the case of the error message "device malfunction". This will suspend running ventilation for approximately 30 seconds. Maquet is providing a software update to eliminate incorrect "Device Malfunction" errors. Users should note that any "Device Malfunction" errors after the installation of the software update are valid.

Device

Weinmann Medumat Transport Ventilator
  • Model / Serial
    Weinmann Medumat Transport VentilatorAll serial numbersARTG Number: 190246
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA