Alerte Ou Avis De Sécurité sur Puma and Beatle battery powered wheelchairs

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Movingpeople.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2008/052
  • Numéro de l'événement
    CON020687
  • Date
    2008-07-21
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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

  • Modèle / numéro de série
  • Description du dispositif
    Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare.
  • Manufacturer

Manufacturer

  • Source
    MHRA