Events

Safety Alert for Fabius MRI - Anesthesia Workstation - Technical Name: Anesthesia Device - Registration 10407370065 - Risk Class III (High Risk) Model: Fabius MRI - Series Affected in ANNEX (Distribution Map).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Dräger Indústria e Comércio Ltda; Dräger Medical GmbH.

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
    1660
  • Date
    2015-08-18
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company advises the user 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. Follow all the information and warnings that are in the instruction manual of the equipment. "In addition, users should follow all the information that is presented during installation and training by Dräger training team in Brazil. "During Fabius MRI installations and training the Dräger team in Brazil presents the instructions for use and warnings regarding the product, and in the case of the Fabius MRI the team still sends a letter of recommendation in order to optimize the use and operation of the Fabius MRI and to reduce risks, within the letter is specified that the user must respect the area delimitation ranges: To ensure that the Fabius MRI operate safely and without interference in the proximity of a system for MRI. See attached letter. (Annex 2) In every installation process Dräger delimits the safety area with a yellow stripe with a limit of 40mTesla. According to the attached letter. Annex 2 "(ANNEX)
  • Reason
    The manufacturer dräger has received reports of occurrences in which the fabius mri or parts of the apparatus have been 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 fabius mri parts and injure people. according to the company, the operating instructions and the marking of the appliance clearly state that the appliance is to be used only in areas where the field strength does not exceed 40mtesla. according to the company, the reported cases resulted from the fact that the device was moved from the 40mtesla area and the marking of the device while it was not in use.
  • Action
    The company is alerting users to the possibility of the equipment being attracted by magnetic resonance magnetic field, when displaced from the limit area of ​​40mTesla (400 Gauss). The company will send a Letter to the clients calling attention to the problem and giving guidelines of the procedures to avoid the problem (APPENDIX). Code PR54354_54316_TSB 5

Device

Fabius MRI - Anesthesia Workstation - Technical Name: Anesthesia Device - Registration 1040737006...

Manufacturer

Dräger Indústria e Comércio Ltda; Dräger Medical GmbH