Events

Alerte Ou Avis De Sécurité sur Oxylog 3000 emergency/transport ventilators

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/2010/092
  • Numéro de l'événement
    CON100176
  • Date
    2010-11-30
  • Date de publication de l'événement
    2010-11-30
  • 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/CON100176?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
    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
  • Modèle / numéro de série
  • Description du dispositif
    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