Events

Retiro De Equipo (Recall) de B20, B30, B40 Patient Monitors (used for ECG monitoring)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty 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-2013-RN-01027-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-02
  • 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-2013-RN-01027-1
  • 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 b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under estimated in this situation and treatment of the patient can be delayed.Please note that there is no issue when the monitor starts with impedance respiration set in the off position.
  • Acción
    GE Healthcare is providing users with work around instructions to follow until a software correction is available.

Device

B20, B30, B40 Patient Monitors (used for ECG monitoring)
  • Modelo / Serial
    B20, B30, B40 Patient Monitors (used for ECG monitoring)Serial Numbers: B20 - SGF11030001WA to SGF13176741WA (software version 1)B30 - SF309380033WA to SF313177120WA (software version 2)B40 - SG211210001WA to SG213172146WA (software version 1)B40 - SJF13010005WA to SJF13180144WA (software version 2)ARTG Number: 92726
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd