Events

Safety Alert for Critical Care Monitoring Station

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Draeger Medical Systems, Inc. || Drägerwerk Ag & Co. Kgaa.

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
    I1803-185
  • Event Number
    2009EBC-0004116
  • Date
    2018-03-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=51
  • 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

Device

Critical Care Monitoring Station
  • Model / Serial
    Infinity Acute Care System and Patient Monitor M540
  • Product Description
    This equipment allows the ventilation of adult and pediatric patients. It allows to select mandatory ventilation modes or ventilatory modes assisted to spontaneous breathing and respiratory tract monitoring, with monitoring and control screens for acute care INFINITY which is carried out through the SMARTCARE software program designed especially for theautomatization of therapeutic measures.
  • Manufacturer
    Draeger Medical Systems, Inc. || Drägerwerk Ag & Co. Kgaa

Manufacturer

Draeger Medical Systems, Inc. || Drägerwerk Ag & Co. Kgaa