Events

Alerta De Seguridad O Notificaciones De Seguridad para Ventstar disposable breathing systems

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/2014/029
  • Número del evento
    CON437729
  • 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/CON437729?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
    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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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