Events

Safety Alert Or Field Safety Notices for Oxylog 3000 emergency/transport ventilators

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 Draeger.

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/2010/092
  • Event Number
    CON100176
  • Date
    2010-11-30
  • Event Date Posted
    2010-11-30
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON100176?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
    Insufficient ventilation of paediatric patients when using small tidal volumes (50 -100 ml).This problem can result in gas being re-breathed and a potential dangerous rise in co2.The mhra is aware of three incidents in which the oxylog 3000 gave insufficient ventilation to small children where a tidal volume between 50 and100 ml was used. these incidents have occurred due to the dead space volume of the entire breathing circuit being too large to cope with the small set tidal volume.
  • Action
    Ensure that all users are aware of the manufacturer’s Field Safety Notice (FSN). Users should always consider the dead space of ventilator breathing circuits when using small tidal volumes. Be aware that Draeger breathing circuits for use with the Oxylog 3000 (disposable and resusable) have a dead space of 33 ml and 35 ml respectively. If the dead space is not suitable for the intended purpose then consider using an alternative device.

Device

Oxylog 3000 emergency/transport ventilators
  • Model / Serial
  • Product Description
    All Oxylog 3000 emergency/transport ventilators. The Oxylog 3000 is an emergency and transport ventilator capable of delivering tidal volumes (volume of gas inhaled and exhaled per breath) of 50 ml and upwards.
  • Manufacturer
    Draeger

Manufacturer

Draeger