Events

Safety Alert for Vital Signs Monitor

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Dixtal Biomedica Industria y Comercio LTDA..

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
    I1410-440
  • Event Number
    2009EBC-0004751
  • Date
    2014-10-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=193
  • 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 affirms that the equipment can be reinitiated inadvertently during its use without the interaction of the user, leading to the presentation of possible adverse events on the patients.

Device

Vital Signs Monitor
  • Model / Serial
    DX2020
  • Product Description
    Indicated as a monitor of high-capacity physiological parameters for patients who need high degree of monitoring. Indicated to monitor physiological parameters for use in situations such as critical or anesthetic care (adult, pediatric, neonatal).
  • Manufacturer
    Dixtal Biomedica Industria y Comercio LTDA.

Manufacturer

Dixtal Biomedica Industria y Comercio LTDA.