Events

Safety Alert for Mechanical ventilator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

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
    I1705-159
  • Event Number
    2010EBC-0006197
  • Date
    2017-05-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=90
  • 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

Mechanical ventilator
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    The RESPIRONICS V60 ventilator is a support ventilator whose purpose is to increase the patient's breathing. It is indicated for patients who can breathe spontaneously but require mechanical ventilation: patients with chronic respiratory insufficiency or obstructive sleep apnea in a hospital or other institution under the supervision of a doctor. The RESPIRONICS V200 fan is a mechanical fan that works with electricity and is controlled by a microprocessor. It has been designed to be used by qualified medical personnel to provide continuous or intermittent ventilatory support for adult, pediatric and neonatal patients according to medical prescription.
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA