Events

Safety Alert for Anesthesia Machine Fabius GS Premium, Shot, Shot D-M, MRI, plus, plus XL

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Drägerwerk Ag & Co. Kgaa.

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 Number
    2008EBC-0002363 ; 2008EBC-0002325 ; 2008EBC-0002304 ; 2008EBC-0002362 ; 2008EBC-0002386 ; 2014EBC-0010963
  • Date
    2018-03-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=51
  • 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

Anesthesia Machine Fabius GS Premium, Shot, Shot D-M, MRI, plus, plus XL
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    The FABIUS MRI is an inhalation anesthesia machine that has been designed for use in MRI environments of operating rooms and induction and recovery rooms. It can be used in MRI scanner rooms with 1.5 tesla and 3 tesla magnets for a marginal field strength of 40 mtesla (400 gauss) or less. It can be used with o2, n2o and air (air), supplied by a medical gas piping system or externally mounted gas bottles. FABIUS MRI is equipped with a compact respiratory system that offers fresh gas coupling, PEEP (positive pressure at the end of the breath) and pressure limitation. The equipment offers the following ventilation options: volume controlled ventilation; Pressure controlled ventilation; pressure support (optional); simv / ps (optional), manual ventilation; spontaneous breathing FABIUS MRI is suitable for use in magnetic resonance environments of 1.5 tesla and 3 tesla with a magnetic field of 40 mtesla or less
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa

Manufacturer

Drägerwerk Ag & Co. Kgaa