Events

Retiro De Equipo (Recall) de Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators

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-2014-RN-01266-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-04
  • 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-2014-RN-01266-1
  • 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
    Following an internal investigation triggered by reports in the field, it was identified that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. in such a situation the inability to defibrillate or a delay in doing so can as a consequence lead to the death or severe injury of the patient. this potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more.
  • Acción
    Customers are advised to quarantine affected lot numbers and return for replacement This action has been closed-out on 24/05/2016.

Device

Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
  • Modelo / Serial
    Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillatorsProduct Codes: 2059144-001 & 2059144-005 (DF69, 50461)Lot numbers: 21003-0770, 21113-0777 & 21220-0771ARTG number: 208134
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd