Events

Alerte Ou Avis De Sécurité sur Powered wheelchairs: Harrier range

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 Invacare.

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/2012/060
  • Numéro de l'événement
    CON180656
  • Date
    2012-08-22
  • Date de publication de l'événement
    2012-08-22
  • 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/CON180656?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
    The drive wheel may detach from the wheelchair, as a result of being incorrectly refitted due to inadequate service/maintenance instructions in the technical manual.  the manufacturer published a field safety notice (fsn) in april 2012 to notify technicians of the revised removal / refitting procedure. the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Action
    Ensure that technicians responsible for maintenance of Harrier wheelchairs: have a copy of the amended procedure – this is attached to the Field Safety Notice, and can also be downloaded from the Invacare website (external link) are aware of the revised guidance regarding removal and refitting of the drive wheel inform Invacare that the FSN has been received and that the revised procedure has been reviewed and understood.

Device

Powered wheelchairs: Harrier range
  • Modèle / numéro de série
  • Description du dispositif
    Powered wheelchairs. All chairs in the Harrier range.
  • Manufacturer
    Invacare

Manufacturer

Invacare