Events

Retiro De Equipo (Recall) de Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual 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-00738-3
  • Clase de Riesgo del Evento
    Class I
  • 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-00738-3
  • 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
    Some heartstart mrx monitor/defibrillators may contain compromised electronic components and present the following behaviours:·in automatic external defibrillator (aed) mode, the mrx may have difficulty interpreting the pads ecg waveform. the mrx may incorrectly analyse the rhythm or may fail to analyse the rhythm.· in manual defibrillation mode, if the pads/paddles ecg signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.· when using q-cpr measurement and feedback, the feedback on ventilation rate may be inaccurate.
  • Acción
    Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions.

Device

Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M...
  • Modelo / Serial
    Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual defibrillator)Multiple affected units ARTG 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