Events

Alerta De Seguridad O Notificaciones De Seguridad para Oxylog 3000 emergency/transport ventilators

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Draeger.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2010/092
  • Número del evento
    CON100176
  • Fecha
    2010-11-30
  • Fecha de publicación del evento
    2010-11-30
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON100176?tabName=allTabs
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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