Events

Rappel de GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-00906-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-06
  • 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-00906-1
  • 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
    Getinge have identified an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the eds8. this potential for malfunction is caused by a device design issue. it is identified that the delivered pressure and flow rate of the eds8 compressor is too low. under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5l/min airflow required to properly dry/store the endoscopes.Getinge have received several complaints related to this issue, but there was no reported user or patient injury.
  • Action
    Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.

Device

GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor
  • Modèle / numéro de série
    GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor Model Numbers: 01039717 – Right hinge EDS8-R and 01039716 – Left hinge EDS8-L ARTG Number: 276061(Getinge Australia Pty Ltd - Endoscope drying/storage chamber)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA