Events

Retiro De Equipo (Recall) de CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier)

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-01109-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-31
  • 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-01109-1
  • 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
    Non-invasive blood pressure (nibp) - auto-cycling not starting/stopping, nibp measurement not performed if network time update occurs at same time, infants limits are incorrect. ecg- wrong ecg bandwidth in e-psm(p) or e-(p)re(s)tn module. changing primary ecg lead selection will not change primary measurement in pdm or tram.Central monitor- a temporarily hidden alarm message will not reactivate if different alarm is acknowledged, audible alarm missing after broken network connection, ecg not shown on icentral, standby doesn't end, & incorrect labelling on v leads.Ventilation alarms- incorrect display of airway pressure in bed to bed view, spirometry alarm limits can't be changed.General- alarm off issues in small parameter window, auto-discharge doesn't erase data, invasive pressure lables incorrect.Tram -missing service alarm bed to bed view doesn't show highest st value in s/5 network, missing remote alarm & avoa alarm, monitor disconnect alarms not restored.
  • Acción
    GE Healthcare is advising users of work around instructions to follow as an interim measure. GE is providing users with a laminated sheet summarising the work around instructions to keep near the affected units for easy reference until the software update is implemented to correct the issues. This action has been closed-out on 12/02/2016.

Device

CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (wi...

Manufacturer

GE Healthcare Australia Pty Ltd