We provide a breakdown of the adverse event reports received by FDA during a 10-year period (2008-2017). Reports were manually categorized into eight mutually-exclusive event types. Thermal events were further sub-categorized by probable root cause. Objects that became projectiles were sub-categorized. Adverse events related to MR systems consistent with the known hazards of the MR environment continue to be reported to FDA. Thermal events were the most commonly reported serious injury (59% of analyzed reports). Mechanical events (11%), projectile events (9%), image quality issues (6%), and acoustic events (6%) were also observed.
This abstract and the presentation materials are available to members only; a login is required.