Events

Safety Alert Or Field Safety Notices for Ventstar disposable breathing systems

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/2014/029
  • Event Number
    CON437729
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437729?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
    Risk of inhalation of foreign particles. due to a manufacturing issue, there is the potential for loose adhesive residue to be inside the breathing systems.  this may enter the lungs if affected devices are used.
  • Action
    Identify affected devices. If alternative devices from unaffected batches are available in your stocks: quarantine affected devices return them to Draeger and request replacements. If no alternative devices are available in your stocks: continue to use affected breathing systems carry out the check described in Draeger’s Field Safety Notice exercise caution in use. Contact Draeger to acknowledge receipt of the Field Safety Notice. Anaesthetists Theatre practitioners Consultant intensivists

Device

Ventstar disposable breathing systems
  • Model / Serial
  • Product Description
    Ventstar disposable breathing systems.  Part numbers 2M86841 and 2M86791. Specific batch numbers affected. The following products are affected by this action: Device description Part number Batch number (from – to inclusive) Packaging box set 2M86841 330384.001 - 331661.002 Hose packaging 2M86791 330384.001 - 331661.002 Affected devices were manufactured from January 2013 to April 2014 inclusive. These breathing systems are designed for use with the Oxylog 2000 ventilator, which is an emergency and transport ventilator. If relevant to you, the national supply codes are as follows: England NPC: FDB675 Breathing Circuit Oxylog 2000 Disposable Circuit 1.8m
  • Manufacturer
    Draeger

Manufacturer

Draeger