Events

Retiro De Equipo (Recall) de Zoll X Series Defibrillators with system software version 02.10.02.00 or higher

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zoll Medical 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-2014-RN-00348-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-20
  • 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-2014-RN-00348-1
  • 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
    Zoll medical corporation has received 8 field reports where the device displayed an internal error reset required message and then entered acontinuous “system reset” loop. the device cannot be used if it is in a continuous system reset loop. zoll medical's investigation has identified a software error associated with the device's “full disclosure log.” the error may occur during specific conditions, and in particular when the full disclosure log reaches its memory capacity (150 cases) due to invalid data in the overwriting of a full disclosure log. the probability of having an event is low under normal operating conditions.
  • Acción
    Customers who are having devices with the affected software versions are advised to immediately erase the device full disclosure log per the instructions provided in the customer letters. Users should continue to erase the device log once/month (or before 150 cases are stored in the log) until the device software has been updated. To permanently mitigate the issue, a software upgrade pack will be provided to customers which is anticipated to be available by the week commencing March 24, 2014.

Device

Zoll X Series Defibrillators with system software version 02.10.02.00 or higher

Manufacturer

Zoll Medical Australia Pty Ltd