Events

Alerte De Sécurité sur Posture belt adapted to the wheelchair

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 N/A.

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
    804
  • Date
    2005-05-05
  • 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
    ANVISA through the Technovigilance Unit will be investigating if the same occurrence has been happening at the national level. If you are aware of an identical case, please contact the TechnoVigilance Unit by calling 061 - 448.1331 or 448.1485, by fax 061 - 448.1059 or by electronic means tecnovigilancia@anvisa.gov.br.
  • Cause
    "serious incidents - some of which resulted in death - were associated with the use of poorly fitted or adjusted wheelchair seat belts, which led to slipping the seat belt in the neck. all incidents have occurred with pelvic belts, this risk exists for all or other types of belts. ".
  • Action
    "Where the belt is not adjusted by the manufacturer of the wheelchair, the belt dealer shall provide the appropriate information, including data on the compatibility of the belt with the wheelchair, as well as instructions for adjustment, adjustment and maintenance in such a way as to The adjustment of the belt should be checked regularly to ensure that this posture is maintained. Inspection and maintenance of the seat belts, as well as of their adaptations to the seat, should be included in the preventive maintenance program of the seat. "The research has shown that these incidents can occur with belt deviations from the correct position of only 15 cm. The risk is higher for individuals who have some degree of mental deficiency, reduced motor coordination or myasthenia of the upper limbs."

Device

Posture belt adapted to the wheelchair
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA