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
    I1606-240
  • Event Number
    2012EBC-0008670
  • Date
    2016-06-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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 detected that there is a possibility that the visualization of the respiratory frequency partially masks the first digit of the result of the etco2, although the curve related to the parameter displayed on the equipment will allow to evaluate the clinical condition of the patient, the described situation supposes a high risk, which can lead to potentially serious adverse events occurring on the patient.

Device

unkown device
  • Model / Serial
    LIFEPAK 15
  • 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 parocardia.
  • Manufacturer
    Physio Control, Inc

Manufacturer

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