Events

Safety Alert for SCHILLER defibrillator

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

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
    A1604-138
  • Event Number
    2009EBC-0003126
  • Date
    2016-04-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=148
  • 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 a possible security problem where the software does not allow the user to manually analyze the patient, generating potential risks due to not being able to perform the download on demand, leading to potential adverse events on the patients.

Device

SCHILLER defibrillator
  • Model / Serial
    FRED EASYPORT
  • Product Description
    This team diagnoses and treats cardiorespiratory arrest by ventricular fibrillation or pulseless ventricular tachycardia, restoring an effective heart rate and mechanically by emitting a pulse of direct current.
  • Manufacturer
    Schiller Ag

Manufacturer

Schiller Ag