Events

Recall of Fabius Anaesthesia Machine

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical 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-00835-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00835-1
  • 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
    Some units did not pass the high voltage test during the final checking of the fabius by the manufacturer. investigations carried out revealed that on some power supply units, the required minimum clearance between an electrical component and the unit housing was not maintained. under the influence of mechanical forces (e.G., movement of the device), this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. when such faults occur, the standard required manual ventilation is possible, an acoustic alarm is generated and the indicators on the device flash.
  • Action
    As an interim measure, Draeger Medical is advising users to switch over to manual ventilation mode should users experience a failure of the automatic ventilation function. The power supply units will be replaced as a permanent correction.

Device

Fabius Anaesthesia Machine
  • Model / Serial
    Fabius Anaesthesia MachineSupplied between February to July 2013Serial Number: ASEC-0203ARTG Number: 104223
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd