Events

Safety Alert for emergency ventilator and transport

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
    R1606-245
  • Event Number
    2009EBC-0003135 ; 2011EBC-0006883
  • Date
    2016-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=136
  • 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 detected isolated cases of leaks in the retention valve (inspiratory circuit) of the pediatric ventilator tubes of the referenced equipment, causing re-inhalation and an increase in co2 levels, which can lead to the potential occurrence of serious adverse events. the patients.

Device

emergency ventilator and transport
  • Model / Serial
    references 5704954, specific lots.
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Indicated for emergency ventilation and transportation cycled by time, controlled by volume and pressure support for patients who need mandatory or assisted ventilation.
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa

Manufacturer

Drägerwerk Ag & Co. Kgaa