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-00188-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-21
  • 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-00188-1
  • 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
    When used in hospital transport and pre-hospital (ems) environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear also could cause the mrx to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.
  • Acción
    Philips will be inspecting affected units and implementing hardware corrections if required. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. However, customers are advised to ensure that ongoing therapy connection inspections are undertaken on MRx devices to detect wear. Customers are advised to remove affected devices immediately from use and contact Philips to arrange service.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel Numbers: M3535A, M3536A, M3536J, M3536, & M3536MCSerial Numbers:M3535A: US00100104 - US00572207M3536A: US00100902 - US00543688M3536J: US00209838 - US0332675M3536M: US00500002 - US00500009M3536MC: US00500002 - US00500028ARTG 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