Events

Safety Alert for unkown device

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
    I1804-241
  • Event Number
    2008EBC-0002497
  • Date
    2018-04-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • 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

Device

unkown device
  • Model / Serial
    LIFEPAK 20E
  • Product Classification
    Cardiovascular Devices
  • Product Description
    This equipment is indicated to be used in the patient in cardiopulmonary arrest. The patient must be unconscious, without spontaneous breathing, without signs of circulation (no pulse). It can be used additionally as a cardioverter / defibrillator according to medical criteria depending on the cardiac arrhythmia that the patient presents.
  • Manufacturer
    Physio Control , Inc

Manufacturer

Physio Control , Inc
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA