Events

Alerte Ou Avis De Sécurité sur Tec 6 Plus Desflurane vaporiser

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par GE Healthcare (formerly Datex-Ohmeda).

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2009/072
  • Numéro de l'événement
    CON062635
  • Date
    2009-11-09
  • Date de publication de l'événement
    2009-11-09
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON062635?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    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)