Events

Retiro De Equipo (Recall) de CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors)

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-2014-RN-00659-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-24
  • 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-00659-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the carescape monitor b850, b650 or b450. when connecting the pdm (patient data module) to the carescape b850, b650 or b450 monitor with software version 2, the pdm may not start communicating to the monitor and loss of the pdm parameters could occur. this issue happens after the following sequence of events:1. the pdm is connected to a transport pro or solar monitor.2. at least one arrhythmia or st-change snapshot is saved in the pdm.3. the pdm is then connected to the carescape bx50 monitor.4. more than 740 arrhythmia or st-change snapshots are then saved in the pdm.5. the pdm is then disconnected and connected back to the carescape bx50 monitor.
  • Acción
    Customers are advised to follow these instructions provided in the customer letter to configure the CARESCAPE Bx50 monitor to store snapshots locally only and to prevent the PDM from starting to store the snapshots. A PDM that has exceeded the snapshot quantity and becomes unresponsive to CARESCAPE Bx50 monitors can be reset by connecting it to a Solar or Transport Pro monitor and doing a discharge. This process may need to be performed multiple times to clear all of the snapshot data. GE Healthcare will implement a software solution a permanent fix. This action has been closed-out on 02/02/2016.

Device

CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient m...
  • Modelo / Serial
    CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors)ARTG Number: 115304
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd