Events

Safety Alert for Controlled ventilator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hamilton Medical 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
    I1609-384
  • Event Number
    2008EBC-0001977
  • Date
    2016-09-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 it has detected a blockage of the equipment caused by a loop in the software when performing the spo2 measurement, the equipment must be updated to version 2.0.2, the failure could lead to potentially adverse events occur on patients.

Device

Controlled ventilator
  • Model / Serial
    C3, serial 2327
  • Product Description
    It is used in airway obstruction, respiratory failure, breathing difficulties and all traumas, injuries or diseases that can interfere with breathing
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG