Events

Retiro De Equipo (Recall) de Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care 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-00488-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-29
  • 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-00488-1
  • 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 gas sampling pump failure associated with the compact airway gas modules. loosening of the gas sampling pump hex screw in the module pump may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. if this issue occurs, the monitor will show an alarm note on monitor screen of either "low gas sample flow" or "check sample gas out".
  • Acción
    GE Healthcare will implement a correction for the affected modules. If the monitor is showing an alarm of “Low gas sample flow” or “Check sample gas out”, users are advised to check the following before continued use: 1. Check the water trap is not full or occluded. If full or occluded, empty/change the water trap. 2. Check gas sampling adapter at patient airway is not occluded. 3. Check sample line is not occluded. If occluded, change new gas sampling line. 4. Check gas exhaust outlet is not occluded. Ensure there is no blockage preventing the sample gas out flow to scavenging. If the above actions do not remove the alarm message(s), it may be due to the issue described above. Users are advised to remove the equipment from use and contact technical support or local service representative. This action has been closed-out on 02/02/2016.

Device

Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monit...
  • Modelo / Serial
    Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors)Affected serial number range # 6704120 - 6778756ARTG Number: 166230
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd