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-00236-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-27
  • 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-00236-1
  • 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 ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause: - loss of demand mode pacing- inability to perform synchronized cardioversion with paddles- disruption of leads ecg monitoring, which could delay appropriate treatmentdefibrillation, fixed mode pacing, ecg monitoring via pads/paddles and other monitoring functions are not impacted by this issue.
  • Acción
    Philips is initiating a hardware upgrade to the affected devices. Users can continue to use the MRx prior to receiving the hardware upgrade while remaining aware of the issues identified above. If the problem occurs refer to the HeartStart MRx Instructions For Use for troubleshooting assistance. Additional workaround instructions are provided in the customer letter.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MCUnits Affected: Serial numbers within the range US00100100 - US00550668ARTG 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