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 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
    I1708-336
  • Event Number
    2012EBC-0008670 ; 2008EBC-0002497
  • Date
    2017-10-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=69
  • 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 that the reading of etco2 can show a "xxx" value intermittently after the start-up during the operation of the equipment, this is due to the contamination of the internal filters of the module, in case of not presenting the condition, the daily tests of the equipment to ensure its use, the condition could lead to adverse events occur on patients.

Device

PHYSIO CONTROL defibrillator
  • Model / Serial
    LIFEPAK 12, LIFEPAK 15 with EtCO2 functionality
  • 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
    Physio Control , Inc

Manufacturer

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