Events

Rappel de Drager Fabius Anaesthesia Machine - Fabius Tiro

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00640-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-23
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00640-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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