Events

Retiro De Equipo (Recall) de Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML 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-00543-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-15
  • 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-00543-1
  • 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 a potential safety issue due to failure of the carbon dioxide detector associated with single-width airway and extension modules. failure of the carbon dioxide detector in single-width airway and extension modules may cause a slow continuous decrease of measured et-/fico2 values. incorrect et co2/fi co2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low co2 values.
  • Acción
    GE is providing calibration instructions to assist their customers to determine if their module is affected. If the carbon dioxide reading is out of range after the first successful calibration procedure end users are advised to discontinue use and contact a GE service representative. GE will arrange with customers for a correction to ensure this issue does not occur. This action has been closed-out on 02/02/2016.

Device

Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Moni...
  • Modelo / Serial
    Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML monitors)Single-width Airway Module E-miniCSerial Numbers: 6818561 to 6898777Extension Modules N-FC & N-FCRECSerial Numbers: 6799191 to 6905206ARTG Number: 166230
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd