Events

Retiro De Equipo (Recall) de Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)

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-00845-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-14
  • 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-00845-1
  • 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 involving the pre-operative check, low pressure leak test at 1% dial setting of the tec 6 and tec 6 plus vaporizers. the low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers, resulting in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. a fresh gas leak in the vaporizer does not affect delivery of the set anaesthetic agent concentration but could result in a reduction in the volume of fresh gas delivered to the breathing system. this can lead to a reduction of flow of oxygen delivered to the patient, resulting in hypoxic gas concentrations and/or a reduction in the volume of anaesthetic agent delivered to the breathing circuit which may cause light anesthesia. the fresh gas leak may release nitrous oxide (n2o) gas into the ambient air and may result in clinician exposure.
  • Acción
    GE Healthcare is providing users with an addendum with directions to perform the low pressure test with the dial turned to 12%. Users are advised by GE to discontinue use of vaporizors if it fails at 12%. If the vaporizer passes, the device can continue to be used. GE will be repairing/replacing the seals on all Tec 6 and Tec 6 Plus vaporizers as a permanent fix in August 2013.

Device

Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured betwee...
  • Modelo / Serial
    Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)ARTG Number: 140207
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd