Events

Retiro De Equipo (Recall) de HeartStart Automated External Defibrillator (AED)

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-2013-RN-00087-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-31
  • 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-2013-RN-00087-2
  • 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 is providing additional instructions for use to advise the user of the correct actions to take in the event an error notification:-if the frx or hs1 aed emits a pattern of 'single chirps' please press the blue i-button on the front of the device. the aed will tell exactly what actions to take to ensure that the device is ready for use. -if at any time during the life of the device, the frx or hs1 aed emitted or begins to emit a pattern of 'triple chirps', it is important that the device is removed from use and a philips representative is contacted. it is a signal that the device requires investigation by philips to ensure that it is ready for use.
  • Acción
    Philips is providing additional instructions advising users to contact Philips technical support if a device error occurs and the device begins to emit a triple chirp, even if the error can be cleared.

Device

HeartStart Automated External Defibrillator (AED)

Manufacturer

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