Events

Safety Alert Or Field Safety Notices for Tec 6 Plus Desflurane vaporiser

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by GE Healthcare (formerly Datex-Ohmeda).

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2009/072
  • Event Number
    CON062635
  • Date
    2009-11-09
  • Event Date Posted
    2009-11-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON062635?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    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)