Events

Safety Alert for Neonatal / Pediatric Ventilator FABIAN HFO and FABIAN EVOLUTION

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Acutronic Medical Systems Agfabrik Im Schiffli.

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
    A1611-535
  • Event Number
    2015EBC-0013518 ; 2013EBC-0009559 ; 2009EBC-0004624 ; 2009EBC-0003567
  • Date
    2016-11-28
  • 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 has determined that with the enablement of the spo2 option, there may be cases in which the operation of the peripheral interface (spi) occurs, producing in turn the loss of image in the user interface and the interruption in ventilation , the team will activate acoustic and visual alarms, the described situation could lead to the occurrence of potentially serious adverse events on the patient.

Device

Neonatal / Pediatric Ventilator FABIAN HFO and FABIAN EVOLUTION
  • Model / Serial
  • Product Description
    Indicated as respiratory support by mechanical ventilation (conventional and / or high frequency among others) for premature patients, newborns and children who so require. Use: neonatal intensive care unit, pediatric intensive care unit, ambulatory care, delivery rooms, etc.).
  • Manufacturer
    Acutronic Medical Systems Agfabrik Im Schiffli

Manufacturer

Acutronic Medical Systems Agfabrik Im Schiffli