Events

Safety Alert for System for Nitric Oxide Monitoring and Administration NOxBOXi

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

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
    I1507-317
  • Event Number
    2015EBC-0012915
  • Date
    2015-07-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=176
  • 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 states that it has detected that the limit in the flow of gas that passes through the device to ensure the values of the correct doses for the patient, can be too close to the tolerance of the flow sensor that is used to control it, therefore, it is it is possible that the alarm "critical management fails" triggers by mistake, which may lead to potential conferments for medical personnel or adverse events on the patient.

Device

System for Nitric Oxide Monitoring and Administration NOxBOXi
  • Model / Serial
  • Product Description
    Administration and monitoring of nitric oxide (NO) for use in therapy with inhaled nitric oxide (ONI).
  • Manufacturer
    Bedfont Scientific Ltd

Manufacturer

Bedfont Scientific Ltd