Events

Safety Alert for Neonatal / Pediatric Ventilator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by F. Stephan Gmbh Medizintechnik.

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
    I1603-118
  • Event Number
    2009EBC-0004429
  • Date
    2016-03-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • 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 reports that the mechanical ventilation was interrupted, due to an incorrect length of the patient circuit made in an artisanal way, situation that caused the system to erroneously calculate the pressure of the circuit, interpreting its increase as an obstruction of the endotracheal lane causing the opening of the safety valve and the alarm related, which could lead to potential adverse events on the patients.

Device

Neonatal / Pediatric Ventilator
  • Model / Serial
    HFO (High Frequency)
  • Product Description
    Mechanical ventilation of premature babies, babies and small children under 20kg. In particular, they are used in the case of respiratory failure caused by ladifusion or respiratory mechanical disorder.
  • Manufacturer
    F. Stephan Gmbh Medizintechnik

Manufacturer

F. Stephan Gmbh Medizintechnik