Events

Recall of Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical Technologies 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-2015-RN-00095-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00095-1
  • 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
    Medical technologies is informing end users of an extremely rare software problem. the problem is withinthe embedded software of the fabian hfo. fabian hfo devices may as a symptom exhibit a halting user interface (touchscreen and/or hard keys). if this happens, it will no longer be possible to adjust the parameter settings. the current ventilation parameters are maintained and there is no interruption to ventilation.
  • Action
    In the event of this problem occurring, it is recommended to transfer the patient to an alternative ventilator. The fabian HFO can continue to be used ONLY in the event where no other ventilator is available in the facility as the single fault condition alarms in the event of a halting user interface, alerting the operator. All fabian HFO ventilators will be updated with software GUI 3.0.2.7 made available by Acutronic. This will prevent the described problem. In addition, Acutronic software has a new watchdog implementation that monitors the state of the serial communication. A failsafe mechanism triggered by watchdog will prevent further similar occurrences from happening. This action has been closed-out on 15/07/2016.

Device

Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2...
  • Model / Serial
    Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200All serial numbers suppliedARTG Number: 185053
  • Manufacturer
    Medical Technologies Pty Ltd

Manufacturer

Medical Technologies Pty Ltd