Events

Alerta De Seguridad para EV1000NI clinical platform

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 Edwards Lifesciences Llc || Edwards Lifesciences 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
    R1712-575
  • Número del evento
    2016EBC-0014585
  • Fecha
    2017-12-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=60
  • 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 informs that it has detected that the devices are susceptible to appear an error message "hrs out of range", when they are six months after the date of manufacture, because said situation could lead to possible delays in the procedures and events. adverse on patients.

Device

EV1000NI clinical platform
  • Modelo / Serial
    HRS sensors, reference EVHRS
  • Descripción del producto
    The NI (non-invasive) clinical platform EV1000NI and its accessories are a monitoring system that shows hemodynamic parameters derived from continuous noninvasive measurements of blood pressure waves. The EV1000NI system helps physicians in the assessment of the patient's physiological status and supports the clinical decision related to hemodynamic optimization. The EV1000NI clinical platform is indicated for use in patients over 18 years of age in whom the balance between cardiac function, fluid status and vascular resistance requires continuous evaluation. Additionally EV1000NI is indicated for use in patients with co-morbidities for which hemodynamic optimization and invasive measures are difficult. EV1000NI measures non-invasive blood pressure and the associated hemodynamic parameters.
  • Manufacturer
    Edwards Lifesciences Llc || Edwards Lifesciences Ag

Manufacturer

Edwards Lifesciences Llc || Edwards Lifesciences Ag