Events

Safety Alert for Defibrillators

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

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
    I1612-572
  • Event Number
    2008EBC-0002632
  • Date
    2016-12-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=109
  • 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 indicates that the energy in the aforementioned defibrillators (aed) may not turn off after completing the daily self-diagnostic test, which could result in the battery being discharged in a day. if this problem occurs, the status indicator remains lit (red), but there is no alarmed sound and defibrillation may not be available when necessary due to battery depletion leading to possible serious adverse events on the patient.

Device

Defibrillators
  • Model / Serial
  • Product Description
    Designed for use in cardiac resuscitation patients at the time of cardiac arrest.
  • Manufacturer
    Nihon Kohden Corporation

Manufacturer

Nihon Kohden Corporation