Events

Alerta De Seguridad para monitor system EV1000 - Edwards

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.

¿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
    I1606-268
  • Número del evento
    2011EBC-0007329
  • Fecha
    2016-06-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • 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 reports that he has identified the need to reinforce the appropriate initial configuration of the power supply according to the operator's manual, following the recommendations given could potentially generate overheating and fire, which can lead to serious adverse events on the patient or the users.

Device

monitor system EV1000 - Edwards
  • Modelo / Serial
    EV1000A, specific serials.
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Indicated as a monitoring platform that indicates the intermittent and continuous hemodynamic measurements related to the evaluation of the essential components of the oxygen supply, as well as the equilibrium between the carrier and the oxygen consumption. The system helps evaluate the patient's condition and supports their clinical decisions related to the optimization of oxygen supply through the control of preload, afterload and contractility. It allows the evaluation of extravascular lung water.
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

Edwards Lifesciences Llc