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 Medtronic Emergency Response Systems, Inc. || 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
    A1702-38
  • Event Number
    2008EBC-0001863 ; 2012EBC-0008670
  • Date
    2017-02-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 states that it has received 34 reports where customers reported that when trying to use the equipment referenced this has stopped working unexpectedly due to an intermittent connection between the battery and its electrical contactors, the equipment in this situation may not be able to deliver the necessary discharge during a attempt to resuscitate, leading to the occurrence of serious events about patients.

Device

PHYSIO CONTROL defibrillator
  • Model / Serial
    LIFEPAK 1000, specific serials.
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Recognized method of terminating certain life-threatening arrhythmias, such as ventricular fibrillation and symptomatic tachycardia-ventricular. 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.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc. || Physio-Control, Inc

Manufacturer

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