MAGNETOM AERA

Description of Event or Problem

SIEMENS HEALTHINEERS WAS NOTIFIED OF A SERIOUS INJURY ASSOCIATED WITH A MAGNETOM AERA SYSTEM. IT WAS COMMUNICATED THAT A FERROMAGNETIC IV POLE WAS ATTRACTED TO THE MAGNET. THE SYSTEM OPERATOR WAS INJURED DURING THIS EVENT, SUFFERING LOSS OF CONSCIOUSNESS FOR APPROXIMATELY 40 SECONDS, A FRACTURED FIBULA, AND A LACERATION BEHIND THE RIGHT EAR. THE OPERATOR WENT TO THE EMERGENCY DEPARTMENT AND RECEIVED SUTURES BEHIND THE EAR AND AN EXAMINATION OF THE LEG INJURY. THE OPERATOR WAS DISCHARGED WITH CRUTCHES AND A PROTECTIVE SHOE, AND WAS INSTRUCTED TO FOLLOW WITH ORTHOPEDICS IN ONE WEEK. DURING THE ORTHOPEDIC APPOINTMENT, IT WAS DETERMINED THAT SURGERY IS REQUIRED TO TREAT THE FIBULA FRACTURE.

Additional Manufacturer Narrative

H3, H6: THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL REPORTABLE INFORMATION AND/OR INVESTIGATION COMPLETION.