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.

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
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 power-related failures since the user prepares the device for initial download or during its use within the first year of distribution, failures may include unexpected power on and off, device lockout or failure to turn on or off, such failures are the as a result of a debris from the manufacturing process located under a component mounted on the power circuit board (pcba) assembly, any of these faults could result in failure to deliver the therapy to the patient and serious injury or death, leading to that potentially serious adverse events occur on patients.


  • Model / Serial
  • Product Description
    It provides stimulation to the heart for the automatic treatment of ventricular arrhythmias that endanger the life of the patient and when they exhibit symptoms of sudden cardiac arrest.
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source