Events

Recall of Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger 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-2018-RN-00158-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00158-1
  • 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
    Dräger has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator.No serious injury has been reported to date.As a precaution drager will be updating relevant units.
  • Action
    Drager is advising they are currently producing replacement motors for the potentially affected devices. Dräger Service have ordered the replacement motor(s) and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange free of charge, the installation and testing of the replacement motor. In the interim, users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for Use.

Device

Dräger Fabius Anaesthesia Machine Device's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS ...
  • Model / Serial
    Dräger Fabius Anaesthesia MachineDevice's : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XLSerial Number's :ASKM-0047, ASKH-0027, ASKH-0168, ASKH-0140, ASKM-0246ARTG Number: 104223Draeger Australia - Anaesthesia system
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd