Safety Alert for FABIUS MRI - ANESTHESIA WORK STATION. Anvisa Registry n ° 10407370065.

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

Dräger has been reported to have occurred in which the Fabius MRI or parts of the apparatus were attracted by magnetic resonance magnetic field. If the Fabius MRI is positioned too close to the resonance equipment, the magnetic force of the MRI can loosen parts of the Fabius MRI and injure people. The instruction manual and the marking of the apparatus specify that the equipment is to be used only in areas where the field strength does not exceed 40mTesla. However, the cases that were reported to the company resulted from the fact that the device was moved through the 40mTesla area and the marking of the device while it was not in use. For this reason, users are advised to make sure that the Fabius MRI is not moved or positioned in areas over 40mTesla (400Gauss), even at times when it is not used on the patient, in addition to following all information and warnings in the operating instructions of the equipment. In addition, users are advised to follow all the information that is presented during installation and training by Dräger's training team in Brazil.