Events

Alerta De Seguridad O Notificaciones De Seguridad para Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds

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 Linet.

¿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/2011/092
  • Número del evento
    CON126110
  • Fecha
    2011-08-18
  • Fecha de publicación del evento
    2011-08-18
  • 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/CON126110?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
    The manufacturer issued a field safety notice (fsn) for this device on 15 july 2011, but has not had sufficient confirmation from users that they have received and acted on this information. a copy of the fsn is in the appendix of this alert and it is also available on the mhra website. this alert has been issued in support of the manufacturer’s actions.
  • Acción
    Ensure that relevant members of staff are aware of the problem. Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.Action by:All those using, managing and maintaining hospital beds. In particular: nurses, maintenance staff and contractors.

Device

Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds
  • Modelo / Serial
  • Descripción del producto
    Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds. Affected serial numbers: Standard: 1739003 – 20053049650 Deluxe: 1752144 – 20053022252
  • Manufacturer
    Linet

Manufacturer

Linet