Events

Safety Alert for monitor system EV1000 - Edwards

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Edwards Lifesciences Llc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1606-268
  • Event Number
    2011EBC-0007329
  • Date
    2016-06-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    EV1000A, specific serials.
  • Product Classification
    Cardiovascular Devices
  • Product Description
    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