Events

Safety Alert for Power Heart Automatic External Defibrillator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Cardiac Science Corporation 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
    I1512-599
  • Event Number
    2010EBC-0005895
  • Date
    2015-12-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=162
  • 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 the referenced electrodes may present a higher impedance than expected, causing a failure in the self-diagnosis and operation of the equipment, leading to the occurrence of potentially adverse events on the patient.

Device

Power Heart Automatic External Defibrillator
  • Model / Serial
    reference 9131-001, lot 141125-02
  • Product Description
    This device is designed to diagnose and monitor the patient's heart rate and deliver shock energy as required. The device is indicated for the emergency treatment of victims who have symptoms of sudden cardiac arrest that do not respond and do not breathe.
  • Manufacturer
    Cardiac Science Corporation Inc.

Manufacturer

Cardiac Science Corporation Inc.