Events

Alerte Ou Avis De Sécurité sur Ibis Comfort wheelchair

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 Handicare B.V.

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/2013/049
  • Numéro de l'événement
    CON295475
  • Date
    2013-07-04
  • Date de publication de l'événement
    2013-07-04
  • 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/CON295475?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
    Handicare has identified a quality issue with the tilt adjustment on ibis comfort wheelchairs. the upper hinge block component used in the tilt mechanism may break. this could cause the seat unit to tip backwards unexpectedly. there is a field safety notice for uk customers.
  • Action
    Identify all affected Ibis Comfort wheelchairs. Contact Handicare or your dealership to arrange exchange of the tilt adjustment component (upper hinge blocks). Dealers should contact Handicare for the instructions for changing the hinge blocks. Dealers should inform Handicare when the component has been replaced.

Device

Ibis Comfort wheelchair
  • Modèle / numéro de série
  • Description du dispositif
    Ibis Comfort wheelchair. Specific serial numbers of chairs manufactured from 29 January to 12 April 2013 inclusive. Photograph showing location of affected hinge block Photograph showing old and new style hinge blocks.
  • Manufacturer
    Handicare B.V

Manufacturer

Handicare B.V