Events

Rappel de Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers range: 22611-24876

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-00203-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-03-09
  • 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-00203-1
  • 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 that under certain conditions, an internal communication error might prevent the safety valve to close automatically. as a consequence, ventilation will stop and a high priority alarm, as well as clinical alarms, will be triggered. getinge are aware of two instances where this issue has caused desaturation but have no reports of resulting permanent injuries.
  • Action
    Getinge will initiate an immediate update of all affected Servo ventilator units during which the firmware of an internal circuit board will be upgraded. Users will be contacted by their Getinge sales or service representative to plan for the update of the ventilator.

Device

Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455 Product: Servo-u Serial Numbers...
  • Modèle / numéro de série
    Servo VentilatorsProduct: Servo-n Serial Numbers range: 1240-1455Product: Servo-u Serial Numbers range: 22611-24876ARTG Numbers: 218345, 162468(Getinge Australia - Ventilator, neonatal/paediatric)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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