Events

Safety Alert for Drager anesthesia machine

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 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
    I1605-192
  • Event Number
    2008DM-0002167
  • Date
    2016-05-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 has identified that after its use a possible involuntary release of the anesthetic agent can be obtained by spontaneous vaporization, where the narcotic agent could splash on the user's face and eyes, which could lead to potentially adverse events occurring to the users.

Device

Drager anesthesia machine
  • Model / Serial
    reference D-VAPOR, all serials.
  • Product Description
    Set of elements that serve to administer anesthetic and medical gases to the patient during anesthesia, both in spontaneous and controlled ventilation.
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa

Manufacturer

Drägerwerk Ag & Co. Kgaa