Events

Safety Alert for anesthesia system Flow-I

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Maquet Critical Care Ab.

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
    I1503-113
  • Event Number
    2011EBC-0008130
  • Date
    2015-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=183
  • 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 o2 and suction modules of the referenced equipment can not be activated or controlled by the "on / off" switch of the suction unit, which could lead to a decrease or loss of the suction capacity, making it difficult keep the patient's airway clear, leading to the potential occurrence of adverse events on patients.

Device

anesthesia system Flow-I
  • Model / Serial
    FLOW-i, specific serial
  • Product Description
    Intended for the administration of anesthesia while controlling the complete ventilation of patients with no ability to breathe, as well as in the support of patients with limited ability to breathe.
  • Manufacturer
    Maquet Critical Care Ab

Manufacturer

Maquet Critical Care Ab
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA