Events

Retiro De Equipo (Recall) de HeartStart FRx, HeartStart Home, and Heartstart OnSite

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2018-RN-00229-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-02
  • 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-2018-RN-00229-1
  • 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
    Philips has become aware of a specific electronic failure with one of the resistors. virtually all of these resistor-related failures were detected through the devices’ automatic self-testing, alerting the user by issuing audible chirps. however, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. to date, philips is aware of 13 instances in which this component failed during treatment, out of more than 45,000 uses in which shock therapy was delivered. in all these instances, the device delivered at least one shock before failure. among the cases for which the patient outcome is known, in overseas jurisdictions, 5 patients died and 2 patients were successfully resuscitated and survived.The in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest patient is in need of shock therapy.
  • Acción
    Upon receipt of the Customer Letter, users are asked to conduct a self-test on their device as per the instructions outlined in the current IFU using the details given below: • Check the pads label for the expiry date, replace if expired • Check the battery label for the expiry date, replace if expired • Depress the blue “i”, listen for the voice prompt to provide device status • Remove and reinsert the battery, allow the self-test to complete. Users are also requested to refresh their understanding of the Audible Chirps from the AED as detailed in the Customer Letter.

Device

HeartStart FRx, HeartStart Home, and Heartstart OnSite
  • Modelo / Serial
    HeartStart FRx, HeartStart Home, and Heartstart OnSiteAll AEDs manufactured between 2002 to 2013 (660,000 units )Possible R92 Resistor FailureARTG Number: 92346 (Philips Electronics Australia Ltd Defibrillator - Non-rechargeable public automated external defibrillator)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA