Events

Safety Alert for infinity acute care system workstation critical care Drager

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
    I1611-534
  • Event Number
    2009EBC-0004116
  • Date
    2016-11-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=112
  • 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 about the possibility that the expected alarms will not occur in the central display module (cockpit) and in the m540 (in none will the visual alarms be affected), likewise, the appropriate audible and visual alarms will normally be present in the ics. which could lead to the occurrence of potentially adverse events on the patients.

Device

infinity acute care system workstation critical care Drager
  • Model / Serial
    IACS with software version VG5.0
  • Product Description
    This equipment allows the ventilation of adult and pediatric patients. It allows the selection of mandatory ventilation modes, ventilation modes, assisted to spontaneous breathing and respiratory monitoring, with monitoring and control screens for the INFINITY acute care system, which is carried out through the SMARTCARE software program specially designed for the automation of therapeutic measures.
  • Manufacturer
    Draeger Medical Systems, Inc. || Drägerwerk Ag & Co. Kgaa

Manufacturer

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