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
    A1605-227
  • Event Number
    2008EBC-0001778
  • Date
    2016-05-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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 identified a potential risk caused by the failure of the f1 fuse, on the transducer alarm alarm card (caw), the fuse can be opened causing a loss of power in the display module, this malfunction creates a momentary loss of information status on the screen (uim) and a "vent inop avea" alarm during the pre-use check during use, which leads to the interruption of ventilation for the patient, which can lead to potentially serious adverse events. about the patient.

Device

lung ventilator

Manufacturer

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