Events

Retiro De Equipo (Recall) de Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, 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-00736-3
  • 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-00736-3
  • 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
    When heartstart mrx defibrillator monitors are used in external transport and ems environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads cpr therapy cable and external paddles cable) and the mrx therapy connection port may experience higher than expected levels of stress causing accelerated wear.
  • Acción
    Philips is revising the Instructions for Use (IFU) to include additional requirements and instructions for ongoing inspections of these devices, informing users that the lifespan of this device is 3 years and is providing support for users needing to replace cables.

Device

Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M...
  • Modelo / Serial
    Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5 and M3536M6 (manual defibrillator)All units manufactured prior to June 2012 (Model / manufacture date is printed on the primary label on the back of battery bay B)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