Events

Recall of Drager Fabius Anaesthesia Machine - Fabius Tiro

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-00640-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00640-1
  • 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
    Whilst conducting production quality checks, dräger became aware of a device where it was possible to dose 100% nitrous oxide. draeger anaesthesia machines are equipped with a mechanical oxygen minimum dosage module (s-orc). this safety feature prevents the user from inadvertently setting hypoxic gas mixtures (with less than 21% oxygen) at the fresh gas mixer when nitrous oxide is selected as one of the carrier gases.In the event of a fault, the s-orc module would not prevent setting a nitrous oxide flow that would result in a hypoxic mixture from being dosed to the patient. the device would deliver exactly the set gas composition, which can be read on the electronic fresh gas flow displays. a hypoxic gas mixture would be immediately visible on the basis of the oxygen monitoring. in addition, visual & audible alarms would be generated if the inspiratory oxygen concentration (fio2) low alarm limit is violated.To date, draeger have not received complaints relating to this issue.
  • Action
    Investigations have determined that the root cause was a burr not being removed from an internal component of the S-ORC during the production process. Draeger are advising that they are currently producing replacement motors for the potentially affected devices. Draeger Service has ordered the replacement motors and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange the installation and testing of the replacement motor. In the meantime, users may continue to use the installed devices. However, it is important to ensure that the instructions, notes and warnings in the relevant Instructions For Use are observed and that the alarms are not disabled on the corresponding Oxygen2 and Nitrous Oxide monitoring devices. Always set gas flows so that at least 21% oxygen is dosed. If the anaesthesia machine drops below the low alarm limit for Fi02 and generates an alarm, please check the settings and adjust them as required.

Device

Drager Fabius Anaesthesia Machine - Fabius Tiro
  • Model / Serial
    Drager Fabius Anaesthesia Machine - Fabius Tiro Serial Numbers: ASKM-0203 and ASKM-0197 ARTG Number:104223(Draeger Australia Pty Ltd - Anaesthesia system)
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd