Retiro De Equipo (Recall) de LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AED)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Physio-Control 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-00211-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-08
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    In some rare situations, the charge-pak replaceable battery charger has not lasted two years because of an internal electrical failure that leads to early internal battery depletion.
  • Acción
    End users are instructed to continue to monitor the AED routinely for warning indicators as stated in the instructions for use. If it is determined that the device is affected by the early battery depletion issue a permanent replacement device will be provided. This action has been closed-out on 04/04/2017.

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA