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-00231-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-03
  • 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-00231-1
  • 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
    An internal component on the heartstart mrx therapy board may malfunction potentially affecting the ability to deliver therapy. specifically, the mrx may be unable to charge and deliver a shock. in addition, when used for external pacing, the malfunction may result in a loss of capture during pacing.The mrx may display a red x in the ready for use (rfu) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing.
  • Acción
    Philips is initiating a correction to the affected devices. A hardware upgrade will be provided to customers with affected devices. Philips is advising users that they can continue to use their MRx prior to receiving the hardware upgrade, provided that if it is observed that the MRx is displaying a Red X in the Ready For Use (RFU) indicator during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this occurs, remove from use and call for a service. Identify a readily available back up defibrillator to use in the event the affected MRx fails to deliver therapy.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers: M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464, 861483, and 861491Units Affected: Serial numbers within the range US00100204 to US00570921ARTG 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