Events

Alerta De Seguridad para Patient Browser and Content Manager. Anvisa Registry n ° 80042070025.

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; 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
    1732
  • Fecha
    2015-11-16
  • 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
    If a reference data sequence is deselected and the error persists, the magnitude of the offset or distortion will vary depending on the differences between the two data sequences. In some cases the displacement or distortion will be clearly visible when the plan is used in a Brainlab planning or navigation system. However, an offset may also not be so obvious. If a displacement or distortion occurs and is not detected during data review, diverting the information displayed in Brainlab's planning or navigation software may have a negative impact on a patient's clinical decisions. No negative effect on patients related to this problem has been reported to Brainlab by any customer to date.
  • Causa
    By actively deselecting a merged reference data stream in content manager (the default setting is "selected"), a point, an object, or a path may appear to be offset and / or distorted in the brainlab navigation or planning software that is used subsequently.
  • Acción
    Field correction (software update). Recommendations for product users: Do not deselect individual data streams where a Point, an Object, or a Trajectory is planned. If you are unsure about the data sequence in which the Point, Object, or Trajectory was planned, do not deselect any of the contents of the plan. Instead, open the whole plane. Before beginning treatment of the patient, always check the plausibility of all the information inputs and outputs of the device. Company code for the field action: CAPA-20150804-001474. Access and read the warning message published by the manufacturer, available at: http://portal.anvisa.gov.br/wps/wcm/connect/df7295804a9dfab290a4b7218f91a449/Seguran%C3%A7a+em+Campo_1732.pdf ? MOD = AJPERES

Device

Patient Browser and Content Manager. Anvisa Registry n ° 80042070025.

Manufacturer

Brainlab Ltda; Brainlab AG
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA