Events

Retiro De Equipo (Recall) de Philips HeartStart MRx cardiac 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-2012-RN-00735-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-19
  • 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-2012-RN-00735-3
  • 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
    Due to a corrupt data card some heartstart mrx defibrillator/monitors manufactured within these time periods may have incomplete 12-lead program files, and if so will present the following behaviour:- the device cannot analyse a 12-lead ecg report. due to this a user cannot view, print or transmit a 12-lead ecg.- a message 'cannot analyse ecg' is displayed on the mrx when an attempt to acquire a 12-lead report is made.
  • Acción
    User may continue to use an affected device, however the 12 lead report will not be generated, Philips Healthcare recommends have a back up device available. Philips Healthcare will be providing a software update to permanently correct the issue.

Device

Philips HeartStart MRx cardiac monitor / defibrillator
  • Modelo / Serial
    Philips HeartStart MRx cardiac monitor / defibrillator, model number: M3536A with R.03.03 software and 12 Lead option (manual defibrillator)Model number: M3536A with R.03.03 software and 12 Lead option (or with the capability to install 12 lead option)Manufactured between April 17 2012 and May 8 2012Multiple serial numbersARTG number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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