Events

Retiro De Equipo (Recall) de 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-2013-RN-00622-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-18
  • 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-00622-1
  • 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
    The mrx could deliver a non-synchronised shock in the cardioversion mode if the user rotates the therapy knob while simultaneously pressing the 'sync' button, then charges the mrx and presses the shock button. delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation.Additionally, the label affixed to the top of the mrx device is not consistent with the instructions for use with regard to the specific steps for the set up of delivery of a synchronised shock.
  • Acción
    Philips Healthcare are providing users with work around instruction as an interim measure. A software upgrade and device label revision will be supplied to users as a permanent fix. This action has been closed-out on 11/02/2016.

Device

HeartStart MRx Monitor / Defibrillator
  • Modelo / Serial
    HeartStart MRx Monitor / DefibrillatorModel numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6Serial Numbers: All serial numbers between US00100100 to US00567299Manufactured between February 2004 and May 2013ARTG Number: 95661
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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