Events

Alerta De Seguridad O Notificaciones De Seguridad para Storm 3, Storm TT, Typhoon and Typhoon II 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 Invacare.

¿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/2008/077
  • Número del evento
    CON028564
  • Fecha
    2008-10-27
  • 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/CON028564
  • 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 original tie-down brackets fitted to these wheelchairs are not suitable for the new heavy duty four point webbing tie-down systems manufactured by unwin safety systems limited. the mhra previously issued mda/2008/014 in march 2008 to alert users of typhoon and typhoon ii powered wheelchairs weighing over 140kg that there was no commercially available four point webbing tie-down system suitable to allow these wheelchairs to be used as a seat in a motor vehicle. mda/2008/035 was subsequently issued in may 2008, on the same subject, for some storm and all storm tt powered wheelchairs that weighed over 140kg. in june 2008 invacare issued a product update (ref pu249) that announced the availability of a new tie-down system from unwin safety systems to enable these wheelchair models to be used as a seat in a motor vehicle. however, the product update failed to advise that the existing tie-down brackets must be replaced by new brackets prior to use of the new tie-down. the original brackets have edges that can damage the webbing of the new tie-down; the new brackets are designed to reduce this risk. in the event of a vehicle impact damaged webbing could fail, leading to injury of the wheelchair occupant or others. the new tie-down brackets are available free of charge from invacare, complete with fitting instructions, for any of the affected wheelchairs. the reference numbers are: sp1523487 – for storm3 (including true track (tt) sp1523488 – for typhoon i sp1523486 – for typhoon ii note: invacare is not providing brackets for storm or storm2 models.
  • Acción
    Trace all Invacare Storm 3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs. Inform the users of these wheelchairs that they should not be transported in a vehicle using the new Unwin tie-down system until their existing tie-down brackets have been updated. Contact Invacare on telephone number 01656 647 327 to obtain the appropriate brackets and make arrangements for their fitting to the wheelchair.

Device

Storm 3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs
  • Modelo / Serial
  • Descripción del producto
    Storm 3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare. All Storm3, Storm TT, Typhoon and Typhoon II powered wheelchairs purchased before 21 July 2008.
  • Manufacturer
    Invacare

Manufacturer

Invacare