Events

Safety Alert for EV1000NI clinical platform

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 || Edwards Lifesciences Ag.

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
    R1712-575
  • Event Number
    2016EBC-0014585
  • Date
    2017-12-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=60
  • 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 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
  • Model / Serial
    HRS sensors, reference EVHRS
  • Product Description
    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