Events

Alerte Ou Avis De Sécurité sur 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 Pride Mobility Products Ltd.

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/2014/011
  • Numéro de l'événement
    CON395248
  • Date
    2014-03-21
  • Date de publication de l'événement
    2014-03-21
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON395248?tabName=allTabs
  • 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
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    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