Events

Retiro De Equipo (Recall) 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)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-01295-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-04
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01295-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / 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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd