Events

Retiro De Equipo (Recall) de Defibrillator/pacer SLIM corpuls3

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-00979-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-15
  • 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-00979-1
  • 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
    Due to too little distance between a circuit board and the housing, there is the possibility that a component on that circuit board could be damaged mechanically. this impairs the radio connection between the modules. the user can recognise this, if a respective error message (ie, “no connection to defibrillator unit” or “no connection to p-box” ) is displayed. impairment of the radio connection between the modules could result in the inability to: - perform full patient monitoring; and - correctly adjust and operate a therapy function of the device. vibrations have been found to increase the likelihood of this malfunction. due to this issue, diagnosis and therapy are delayed, because the measurement and therapy functions cannot perform without problems.
  • Acción
    Device Technologies Australia (DTA) is advising the customer to connect the module mechanically to form a compact device if the error message is displayed. A permanent correction of the error is only possible by replacing the affected radio module. DTA is arranging replacement of the radio module. This action has been closed-out on 1/06/2016.

Device

Defibrillator/pacer SLIM corpuls3

Manufacturer

Device Technologies Australia Pty Ltd