Events

Retiro De Equipo (Recall) de Powerheart G3 Defibrillation Electrodes (used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E Automatic External Defibrillator (AEDs))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cardiac Science 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-2016-RN-00177-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-17
  • 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-2016-RN-00177-1
  • 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
    Cardiac science has determined powerheart g3 defibrillation electrodes from lot no. 141125-02 may exhibit higher than expected electrical impedance over time. if electrode impedance becomes too high, the powerheart g3 automatic external defibrillator (aed) will fail the electrode self-test performed by the aed and it will not be rescue ready. specifically, if the aed fails the electrode self-test, the status indicator on the aed will be red and the aed will beep. this is standard behaviour when the impedance limit is exceeded. the aed will not be ready for use in a rescue in this state.The reported issue may result in failure to deliver shock therapy when needed and in the worst case could result in serious adverse health consequences, including injury or death. cardiac science is not aware of any instances in which lot no. 141125-02 electrodes failed to work at the time of therapy.
  • Acción
    The sponsor is advising users to identify the affected units and replace the electrodes with the replacement electrodes provided by the sponsor as per the instructions in the customer letter.

Device

Powerheart G3 Defibrillation Electrodes (used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 93...
  • Modelo / Serial
    Powerheart G3 Defibrillation Electrodes (used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E Automatic External Defibrillator (AEDs)) Part Number: 9131-001Lot Number: 141125-02ARTG Numbers: 98893, 113431 and 101284
  • Manufacturer
    Cardiac Science Australia Pty Ltd

Manufacturer

Cardiac Science Australia Pty Ltd