Events

Alerte De Sécurité sur Motorized Wheelchair. Invacare Motorized Wheelchair: (1) Cruiser, (2) Harrier HD, (3) Harrier Plus, (4) Harrier Special, (5) Home and Away, (8) Spectra Plus, (9) Spectra Special. Units manufactured between 1 June 2001 and 26 July 2001

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Invacare UK Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    371
  • Date
    2001-12-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The medical devices agency (mda) has issued a safety alert informing numerous reports received by both the mda and the manufacturer that the steering wheel of the above motorized wheelchair has failed, have been disconnected due to the loosening of the central locking bolt / bolt during use. when this occurs, the user is at risk as he may lose control of the wheelchair and the tipping over chair; this problem may not be evident to the user or to the responsible professional at first sight, if not much later, when events occur. this problem has occurred because a locking thread (which is used to apply a thread-locking component, ie serves to retain the center bolts and prevent loosening during wheel work), has not been properly controlled during manufacture.
  • Action
    Identify and isolate any motorized wheelchair, such as the one above, that has been provided since June 1, 2001. If you are not sure whether your wheelchair is affected, contact the manufacturer on the phone below to check the serial number in the archives. The manufacturer agrees to provide the replacement of the screws and pay the installation costs to the dealers / dealers recognized to repair the problems for the users. To receive the replacement screw, check the serial number, or request additional information by contacting your local representative or directly from Kevin Humphries, Invacare's technical services director, by mail at the address below, by phone at 44 (165) 664- 7327, or fax 44 (165) 664-9016.

Device

Motorized Wheelchair. Invacare Motorized Wheelchair: (1) Cruiser, (2) Harrier HD, (3) Harrier Plu...

Manufacturer

Invacare UK Ltd
  • Source
    ANVSANVISA