Events

Alerte De Sécurité sur KOLIBRI STEREOTECH SYSTEM. Anvisa Registry n ° 80042070005.

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 Brainlab Ltda..

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
    1027
  • Date
    2010-09-01
  • 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
    After conducting a risk assessment of the problem, the company concluded that it is a critical severity problem whose probability of occurrence is remote. According to the company, in Brazil there are 9 units of equipment under risk.
  • Cause
    Attaching the camcorder to the cradle is unreliable due to a manufacturing error. during use, the camera (weighing approximately 3 kg) may detach itself from the stand and fall, which may result in a serious adverse event to the patient or user.
  • Action
    Users / health care professionals should regularly check the camera unit before attaching or transporting the equipment to the mounting screws. To do this, proceed as follows: (1) Close all wheel locks on the equipment support; (2) Place the camera arm in the 90 ° (horizontal) position until it snaps into place; (3) Hold the camera by rotating it about its vertical axis until it reaches the limit; (4) Apply moderate force in the horizontal and vertical direction of the camera unit - there should be no movement between the camera and its interface. More detailed information can be found at http://portal.anvisa.gov.br/wps/wcm/connect/8553ee8043cfc47f9399934eca73f154/Carta+to+Product.pdf?MOD=AJPERES. The registration holder has already initiated the communication with the users of the product and informed that he will correct the products at risk.

Device

KOLIBRI STEREOTECH SYSTEM. Anvisa Registry n ° 80042070005.

Manufacturer

Brainlab Ltda.
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    ANVSANVISA