Events

Alerta De Seguridad O Notificaciones De Seguridad para Puma and Beatle battery 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 Movingpeople.

¿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/2008/052
  • Número del evento
    CON020687
  • Fecha
    2008-07-21
  • 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/CON020687
  • 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
    Some variants of the puma and beatle are too heavy for standard four point webbing tie-down systems for use in a vehicle. a basic puma or beatle battery powered wheelchair can be transported using a four point webbing tie-down rated for a 140 kg wheelchair. however, some wheelchairs have additional features such as seat risers, tilt-in-space functions and powered elevating leg rests etc. therefore, some variants of the puma and beatle battery powered wheelchairs weigh in excess of 140kg and are too heavy for the standard four point webbing tie-down system available for use in a vehicle. guidance on how to verify the weight of the unoccupied wheelchair can also be found in the field safety notice (see appendix). if a vehicle is involved in an impact there is a risk that the tie-down will fail, potentially leading to injury of the wheelchair user and others. the manufacturer has been unable to recommend a tie-down system for wheelchairs weighing over 140 kg and has issued a field safety notice (see appendix) recommending that they are not used as a seat in transport.
  • Acción
    Trace all Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare. Advise users of these wheelchairs not to use the wheelchair as a seat in transport when secured using standard four point webbing tie-downs until such time as they can verify that it weighs less than 140kg.

Device

Puma and Beatle battery powered wheelchairs
  • Modelo / Serial
  • Descripción del producto
    Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare.
  • Manufacturer
    Movingpeople

Manufacturer

Movingpeople
  • Source
    MHRA