Events

Alerta De Seguridad para cryocam system

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 N/A.

¿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
  • Número del evento
    2013EBC-0009606
  • Fecha
    2017-10-11
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=68
  • 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

Device

cryocam system
  • Modelo / Serial
    Deflectable Introducer Flexcath Advance
  • Descripción del producto
    Description of the system CRYOCATH's CRYOCATH technology from MEDTRONIC combines the advantages of cardiac catheter ablation and cardiac ablation CRYOCATH from MEDTRONIC produces cryogenic (extremely cold) controlled conditions in the cooling segment of a long, flexible and bi-directional catheter. The system delivers cryogenic temperatures to the internal walls of a latent heart approaching the heart through the body vasculature from a puncture in the skin. The procedure is done to correct electrophysiological abnormalities that lead to irregular or erratic heartbeats. This selectively destroys (performs ablation) groups of cardiac cells (sites generating the arrhythmia), which causes or propagates the abnormality. System is composed of the console, catheters, electrical and gas connectors (called as umbilicals) and other accessories. The figure below shows the components connected to form the system. Crio universal console: the console houses the electronic components and the software to control and record the procedure, stores and controls the delivery of liquid refrigerant under high pressure through the umbilical cable coaxial to the catheter, recovers the expanded vapor from the catheter refrigerant under vacuum, and Disposes the refrigerant through the hospital waste management system. The hardware controls the safety monitoring system while the software supplies the patient information, user interface, procedure temperature, temperature / time set point in automatic mode and information from Procedure data. Electric umbilical cable: the sterile electric umbilical cable is a cable
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA