Events

Recall of 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)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2013-RN-01295-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01295-1
  • 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
    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...
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd