Events

Alerta De Seguridad para Patient Positioning System Guided by Image

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Brainlab AG.

¿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
    I1406-236
  • Número del evento
    2013EBC-0010225
  • Fecha
    2014-06-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=202
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer affirms that when using radiography, correction and control after fusion on the basis of bone structures, the system can show images of the patient previously loaded and not the digitally reconstructed radiographic image, causing operator confusion due to the change of images and possible incorrect calculations, leading to that potentially adverse events occur on the patient.

Device

Patient Positioning System Guided by Image
  • Modelo / Serial
    EXACTRAC VERO, software version: v.3.0.0, 3.1.0, 3.1.1, 3.2.0 and 3.2.1
  • Descripción del producto
    It has been designed to place the patient at a defined point in the treatment beam emitted by a medical linear accelerator for the performance of radiotherapy stereotactic radiotherapy treatments for the treatment of lesions, tumors and other indications of any part of the body that require the application of radiation. EXACTRAC can also be used to monitor the patient's position during treatment.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    NIDFSINVIMA