Events

Safety Alert for PHYSIO CONTROL defibrillator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Physio Control, Inc || Medtronic Emergency Response Systems, Inc..

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
    R1711-540
  • Event Number
    2012EBC-0008670 ; 2008EBC-0001863
  • Date
    2017-11-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=64
  • 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 identified that the illustrations of the electrodesreferenced show an incorrect location of the electrodes for a baby, the art printed on the product is incorrect (shows the placement of the pink electrode on the back of the baby), on the other hand the illustration on the outer packaging if is correct (showing the placement of the pink electrode on the baby's chest), this situation could lead to potential serious adverse events on the patients.

Device

PHYSIO CONTROL defibrillator
  • Model / Serial
    reduced energy defibrillation electrodes
  • Product Classification
    Cardiovascular Devices
  • Product Description
    It provides stimulation to the heart for the automatic treatment of ventricular arrhythmias that endanger the patient's life and when they exhibit symptoms of sudden cardiac arrest. Recognized method of terminating certain life-threatening arrhythmias, such as ventricular fibrillation and ventricular tachycardia.
  • Manufacturer
    Physio Control, Inc || Medtronic Emergency Response Systems, Inc.

Manufacturer

Physio Control, Inc || Medtronic Emergency Response Systems, Inc.
  • Source
    NIDFSINVIMA