Events

Retiro De Equipo (Recall) de Wireless Link for HeartStart MRx Monitor/Defibrillator

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-2014-RN-00208-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-02-25
  • 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-00208-1
  • 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
    Wireless link may be unable to trasmit data when configured for a specific data flow. this specific condition may only occur when the wireless link is configured to operate in access point mode in data management. if this occurs, the mrx user will be informed of this inability to transmit data via visual notifications on mrx.
  • Acción
    Philips will be installing a software update to correct the issue. Philips is advising MRx users that while awaiting for the software update they can continue to use the Wireless Link with the MRx. If the issue occurs the Wireless Link should be removed from service and Philips Customer Care contacted. This action has been closed-out on 12/02/2016.

Device

Wireless Link for HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Wireless Link for HeartStart MRx Monitor/Defibrillator Serial Numbers: US00100253 and US00561724ARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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