Events

Retiro De Equipo (Recall) de Birdie, Birdie Compact and Flamingo Lifters (Patient Lifters)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Invacare 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-2012-RN-00681-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-20
  • 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-2012-RN-00681-3
  • 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
    Issue 1: the carabineer used to attach the spreader bar to the lifter may show some wear in the case of intensive or severe use. issue 2: during operation by customers, the spreader bar may unintentionally unhook from the carabineer.
  • Acción
    Issue 1: Invacare has informed that they will check and replace the carabineer if the thickness of its sections measures less than 6mm. Issue 2: Invacare has developed retrofit kits and are intending to address this issue by reworking all the affected units.

Device

Birdie, Birdie Compact and Flamingo Lifters (Patient Lifters)
  • Modelo / Serial
    Birdie, Birdie Compact and Flamingo Lifters (Patient Lifters)All Model NumbersARTG Number: 166395
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd