Events

Alerta De Seguridad para KOLIBRI STEREOTECH SYSTEM. Anvisa Registry n ° 80042070005.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Brainlab Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1027
  • Fecha
    2010-09-01
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA