Events

Safety Alert for lung ventilator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Carefusion/ Cardinal Health/ Viasys Respiratory Care/ Viasys || Health Care.

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
    I1502-94
  • Event Number
    2008EBC-0001778
  • Date
    2015-02-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=184
  • 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 states that the new diaphragm / cap developed for the referenced equipment has eliminated the western fugasa, which can translate into an increase of the average pressure of the airway (mpaw) during the calibration, the maximum acceptable interval will be 10 cmh2o for the which pressure regulators must be adjusted to compensate, otherwise it may lead to a delay in the application of the clinical treatment or that potentially adverse events occur on the patient.

Device

lung ventilator

Manufacturer

Carefusion/ Cardinal Health/ Viasys Respiratory Care/ Viasys || Health Care
  • Source
    NIDFSINVIMA