Events

Safety Alert for Draeger mechanical fan AVOID V300, AVOID V500 and BABYLOG VN500

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 || Drager Medical Gmbh.

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
    I1507-329
  • Event Number
    2013EBC-0010354
  • Date
    2015-07-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=175
  • 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 states that it has detected the reduced capacity of the batteries belonging to the optional ps500 external battery, the device will activate the "low battery" sequential alarms, and it will not be possible to predict the remaining operating time until the fan stops, this behavior obeys only to the failure of the batteries and not to a damage in the main unit of ventilation, leading to the occurrence of potentially adverse events for the patient for not having backup supply, in case of absence of main power supply.

Device

Draeger mechanical fan AVOID V300, AVOID V500 and BABYLOG VN500
  • Model / Serial
    equipment that has the optional PS500 external battery module installed.
  • Product Classification
    Anesthesiology Devices
  • Product Description
    The mechanical ventilator avoids V300 is used intra - hospitally to administer invasive and non - invasive ventilatory support to adult, pediatric and neonatal patients through the generation of positive pressure endiversas ventilatory modalities: mandatory, assisted andpontaneous. Simultaneously, the team monitors the mechanics and respiratory function of the patient. Its main clinical indication is to temporarily support respiratory function in those patients who are unable to carry out an effective spontaneous respiration.
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh

Manufacturer

Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh