Events

Alerte Ou Avis De Sécurité sur Ventstar disposable breathing systems

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 Draeger.

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/2014/029
  • Numéro de l'événement
    CON437729
  • 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/CON437729?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
    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
  • Modèle / numéro de série
  • Description du dispositif
    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