Events

Avis De Sécurité sur K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland 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
    Field Safety Notice
  • Numéro de l'événement
    SN2006(08)
  • Date
    2006-11-20
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/k--series-competition-compact-compact-hemi-combi-drive-kid-and-ultra-light-wheelchairs&id=a494f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The wheelchair seat covers manufactured by invacare between february and october 2003 were supplied with a covering material, which did not meet the requirements for flammability defined by the manufacturer.
  • Action
    Ensure that the purchaser and prescribers of these devices within your healthcare institution:   1. Identify all K-series, competition, compact, compact-hemi drive, kid and Ultra light seat covers that were supplied to your healthcare institution in 2003  2. Arrange with your supplier (Invacare Ireland or Lifestyle Mobility) to check the seat cover material.  The inside of the non-flame retardant cover is black while the inside of the flame retardant cover is grey.  3. Ensure that all affected seat covers are replaced with new covers.

Device

K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Modèle / numéro de série
  • Description du dispositif
    K- Series, Competition, Compact, Compact – Hemi Combi Drive, Kid and Ultra Light Wheelchairs
  • Manufacturer
    Invacare

Manufacturer

Invacare