Events

Alerta De Seguridad O Notificaciones De Seguridad para Tec 6 Plus Desflurane vaporiser

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por GE Healthcare (formerly Datex-Ohmeda).

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2009/072
  • Número del evento
    CON062635
  • Fecha
    2009-11-09
  • Fecha de publicación del evento
    2009-11-09
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON062635?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    There is a higher than expected age related failure of an internal component, which has resulted in either over or under delivery of anaesthetic agent to patients.Ge healthcare has found that the internal rotary valve has been failing prematurely. whilst this failure rate is low, it is higher than expected with other types of vaporiser. it is usually perceived that anaesthetic vaporisers are extremely reliable; consequently anaesthetists have continued to use faulty vaporisers in the mistaken belief that it is their agent monitor that has failed.
  • Acción
    Identify all Tec 6 Plus Desflurane vaporisers. Ensure users are made aware of the increased failure rate of these devices. Have procedures in place to ensure that: the vaporiser’s performance is closely monitored the vaporiser is replaced immediately if any problem is suspected the vaporiser performance is regularly checked, as recommended in its user reference manual in sections 6-2 and 6-3.

Device

Tec 6 Plus Desflurane vaporiser
  • Modelo / Serial
  • Descripción del producto
    Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare (formerly Datex-Ohmeda). Also distributed by Baxter Healthcare. This is an electronic vaporiser that was designed specifically for the delivery of Desflurane anaesthetic agent. It heats Desflurane to maintain constant temperature and vapour pressure for consistent output. It has an LED display which indicates vaporiser status (no output; low agent; warm-up; operational; and alarm battery low).
  • Manufacturer
    GE Healthcare (formerly Datex-Ohmeda)

Manufacturer

GE Healthcare (formerly Datex-Ohmeda)