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, Resuscitation System field upgrade kits with Blender

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-01334-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-18
  • 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-01334-1
  • 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 associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/oxygen gas mixture from the unit which could result in hypoxia or hyperoxia.
  • Acción
    GE Healthcare is advising users to perform a blender accuracy check as outlined in the service manual to verify the O2 concentration set at 21% and 100% settings are within the recommended range. If the blender accuracy test results do not meet specification, remove from patient use and contact GE Healthcare. If the blender accuracy results pass, the system is suitable for continued use, however GE is recommending that when delivering oxygen a pulse oximeter is used to monitor the patient. GE Healthcare will be correcting all affected systems as a permanent fix.

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, Resuscitation System field upgrade kits with BlenderARTG Number: 139290
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd