Events

Retiro De Equipo (Recall) de Philips 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-01288-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-09
  • 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-01288-1
  • 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 can be susceptible to one or both of the issues described below:-1.) the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx monitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filterline fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use. a life threatening situation could occur if etco2 is unavailable and the clinician has no other reliable method for determining c02 statusincluding proper intubation without dislodgement.2.) the handle can separate from the mrx housing due to breakage of mounts on the rear case. this is a drop hazard and may potentially cause bodily injury or failure to deliver therapy due to the unit becoming damaged during impact.
  • Acción
    Philips is initiating a correction to affected devices. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel Number: M3535ASerial Numbers: US00100100 to US00552845Model Number: M3536ASerial Numbers: US00100902 to US00552848ARTG 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