Events

Rappel de Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation systems with Blender and Resuscitation System field upgrade kits with Blender (infant radiant warmers)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare 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-2013-RN-01295-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-04
  • 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-2013-RN-01295-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue wherein the oxygen and air wall or tank inlet fittings in the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen gas concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa, the settings of the blender knob will no longer be accurate in the affected units.There is a risk of over delivery or under delivery of oxygen which may result in hyperoxia or hypoxia.
  • Action
    GE Healthcare is advising users to perform a check of blender accuracy as per the Service Manual to verify O2 concentration set at 21% is within 16-26% and the concentration at 100% setting is within 95-105%. GE is providing a Pass/Fail form to be used for these checks. - If the unit is not within these settings, discontinue use and send completed Pass/Fail form to GE in order to get the unit repaired. - If the unit within these settings, continue using the device.

Device

Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation s...
  • Modèle / numéro de série
    Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation systems with Blender and Resuscitation System field upgrade kits with Blender (infant radiant warmers)Multiple serial numbers affectedARTG Number: 139290
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd