Events

Retiro De Equipo (Recall) de CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one

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-2018-RN-00046-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-01-12
  • 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-2018-RN-00046-1
  • 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 become aware of an issue with the carescape central station (cscs) software version 2.0.2 units. after boot-up or system start up, cscs v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the cscs is connected to both the mission critical (mc) and the information exchange (ix) networks. if a no comm notification is displayed, all patient waveforms, parameter data and alarms are lost at the cscs and patients admitted to telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation. there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising customers who are experiencing the NO COMM safety issue to follow instructions outlined on the customer letter to restore communication between the CSCS and patient monitoring devices in the interim. GE will arrange for a software correction to resolve this issue.

Device

CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one
  • Modelo / Serial
    CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one GTIN 00840682109666; Desktop GTIN 00840682109604ARTG Number: 132673 (GE Medical Systems Australia Pty Ltd - Patient monitor, central unit)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd