Events

Alerta De Seguridad O Notificaciones De Seguridad para Turning aids: ReTurn 7400 and ReTurn 7500

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 Handicare AB.

¿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/2014/025
  • Número del evento
    CON432862
  • Fecha
    2014-07-02
  • Fecha de publicación del evento
    2014-07-02
  • 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/CON432862?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 wing handle on the ladder part of the turning aid may become loose, with a risk of harm to the patient and the person operating the device. the manufacturer has developed an inspection protocol, which is set out in its field safety notice (fsn) dated 19 march 2014. handicare has not had sufficient confirmation from users that they have received and acted upon the information contained in the fsn.
  • Acción
    Identify any affected devices as described in the Field Safety Notice. Where appropriate, remove affected components and contact Handicare for replacements. If you service or recondition these devices, make sure you use the latest version of the service manual to inspect the wing handles, catches and ladders.

Device

Turning aids: ReTurn 7400 and ReTurn 7500
  • Modelo / Serial
  • Descripción del producto
    Turning aids: ReTurn 7400 and ReTurn 7500. Specific design is affected. What is affected: The spare part 'wing handles', article number 7322, delivered from June 2009 to July 2011 inclusive. Any ReTurn 7400 or ReTurn 7500 with the ladder attached to the chassis, delivered until May 2011, might have the affected wing handle (see FSN for further details).
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB