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-01268-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-04
  • 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-01268-1
  • 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 handle can separate from the mrx housing due to breakage of mounts on the rear case. separation of the handle from the mrx housing can cause the mrx to fall, potentially injuring the patient or user. in addition, a delay of therapy could occur if the device is damaged by the impact.
  • Acción
    A hardware upgrade will be provided free of charge for all units affected by this issue. Customers are advised to continue to use their MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat the patient per existing protocols. Do not use the handle to carry the MRx. The MRx can be carried in another manner. For example, the MRx shoulder strap or bed rail hook can be used if available on the unit.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/Defibrillator All Models that received an M4760A Handle and Cap Plate Upgrade shipped before 2010ARTG number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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