Events

Alerta De Seguridad O Notificaciones De Seguridad para Primus anaesthetic workstation

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 manufacturer #17429.

¿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/2007/040
  • Número del evento
    CON2031245
  • Fecha
    2007-05-23
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031245
  • 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
    Potential misconnection of the backup oxygen cylinder; the oxygen cylinder inlet is situated alongside an oxygen outlet and both are fitted with the same connector.  a misconnection to the oxygen outlet would prevent backup oxygen supply in the event of oxygen pipeline failure. the use of an oxygen backup cylinder is optional on the primus.  if the backup cylinder is required the user must attach the cylinder, connect its oxygen nist fitting and connect the gas pressure sensor before use.  the primus has the further user option of an oxygen outlet, which is slightly longer and situated alongside the oxygen cylinder inlet fitting at the back of the primus.  this oxygen outlet is the same nist fitting as the oxygen inlet beside it and therefore users can connect the oxygen cylinder to the wrong fitting. the mhra has received a report of this misconnection, which was not detected in the device’s automated pre-use checks or the pre-use checks recommended by the aagbi (association of anaesthetists of great britain and ireland).  the oxygen pressure gauge indicated that the backup oxygen cylinder was full so the misconnection was not apparent to the user.
  • Acción
    Ensure the backup oxygen cylinder’s NIST (non-interchangeable screw threaded) fitting is connected to the appropriate oxygen inlet.  The correct connection guide can be found above the gas inlet block at the back of the device. Users are recommended that pre-use checks should include the disconnection of the oxygen pipeline to ensure the continuity of oxygen supply from the backup cylinder.

Device

Primus anaesthetic workstation
  • Modelo / Serial
  • Descripción del producto
    Primus anaesthetic workstation supplied by Draeger Medical UK Ltd. The Primus anaesthetic workstation is a modern machine with an integrated ventilator and gas monitoring system for the administration of anaesthesia to adults, children and neonates.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429