Events

Safety Alert Or Field Safety Notices for Auxiliary common gas outlet (ACGO) for anaesthetic machine

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.

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 Number
    MDA/2011/108
  • Date
    2011-12-01
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-auxiliary-common-gas-outlet-acgo-for-anaesthetic-machine-no-fresh-gas-flow-to-patient-with-wrong-setting
  • 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
    The accidental, incorrect setting of the ACGO switch will result in no fresh gas flow to the patient.Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in patient barotrauma.
  • Reason
    (ge healthcare) accidental incorrect setting of the acgo switch results in no fresh gas flow to the patient.(mda/2011/108).
  • Action
    If you have these machines, ensure that:the position of the ACGO lever and breathing circuit connections are checked before the start of every case, as recommended by the manufacturers and in the Association of Anaesthetists of Great Britain and Ireland (AAGBI) pre-use checklist -  care is especially recommended for paediatric lists where breathing circuits are changed routinely between patients relevant members of staff have been fully trained in the use of these anaesthetic machines and are aware of the manufacturer’s training guidance produced in collaboration with the Safety Committee of AAGBI – see appendix of PDF below.

Device

Auxiliary common gas outlet (ACGO) for anaesthetic machine
  • Model / Serial
  • Product Description
    Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO).All Aestiva, Aisys, Aespire and Avance anaesthetic machines.Manufactured by GE Healthcare.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    Paul Mardle, UK Regulatory Affairs David Walker, UK Product Manager GE Healthcare Tel: 01707 263 570Email: paul.mardle@med.ge.comor david.walker@med.ge.com
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    MHRA