Events

Alerta De Seguridad O Notificaciones De Seguridad para Powered wheelchairs

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 Pride Mobility Products Ltd.

¿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/2014/011
  • Número del evento
    CON395248
  • Fecha
    2014-03-21
  • Fecha de publicación del evento
    2014-03-21
  • 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/CON395248?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
    Potential for injury should wheelchairs be secured into vehicles incorrectly.  pride mobility has updated their transportation documentation (dated september 2013); this includes safety-critical information.  in particular, the guidance on how to secure powered wheelchairs requiring more than four tie-downs has been clarified. pride mobility issued a field safety notices in october 2013.  however, it is not clear whether users have received and acted upon this new guidance.
  • Acción
    Identify all users who may have a Pride Mobility powered wheelchair that is suitable for occupied use in transport Ensure users and those involved in transporting the wheelchairs are made aware of the revised transportation guidance. Users should follow the revised transportation guidance to ensure that the wheelchairs are being transported correctly. Complete and return the Notification of Updated Transportation Information form (supplied with the Field Safety Notices to Pride Mobility. Action by: All those involved in the provision, prescription, use and transport of wheelchairs. In particular: wheelchair service managers, rehabilitation engineers, occupational therapists and patient transport service managers.

Device

Powered wheelchairs
  • Modelo / Serial
  • Descripción del producto
    Powered wheelchairs manufactured by Pride Mobility Products Ltd. All models suitable for occupied use in vehicles are affected.
  • Manufacturer
    Pride Mobility Products Ltd

Manufacturer

Pride Mobility Products Ltd