QUALITY ELECTRODYNAMICS

Additional Manufacturer Narrative

THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY ROOT CAUSE OF THE BURN WAS DUE TO USER ERROR, NAMELY LACK OF PADS PLACED IN BETWEEN THE LEGS OR BETWEEN THE HAND/ARM AND LEG AS REQUIRED BY THE USER MANUAL WHICH CAUSED EXCESSIVE POWER DEPOSITION IN LOCALIZED ANATOMY. THE COIL HAS REMAINED IN USE SINCE THE (B)(6) 2020 INCIDENT DATE WITH NO OBSERVED ISSUES. NO ADDITIONAL ACTION WILL BE TAKEN.

Description of Event or Problem

PATIENT EXPERIENCED A BURN AFTER A KNEE EXAM USING A 3T 18CH KNEE COIL WITH A GE 3.0T SIGNA ARCHITECT MRI SYSTEM. THE BURN WAS 2-3 INCHES IN DIAMETER, WITH REDNESS AND FORMED A BLISTER AFTER PATIENT LEFT THE SITE. BURN WAS >75% PARTIAL THICKNESS. PATIENT WAS SEEN BY A PHYSICIAN AND DIAGNOSED WITH A SECOND DEGREE BURN WHICH WAS TREATED WITH FIRST AID AND OINTMENT. BURN WAS HEALING WITHOUT FURTHER MEDICAL TREATMENT. PATIENT HAD A KNEE EXAM ON (B)(6) 2020 AND SENT A LETTER TO THE MRI FACILITY ON 13 FEBRUARY 2020 STATING THAT SHE EXPERIENCED A BURN ON HER RIGHT KNEE. THE PATIENT STATED SHE FELT WARMTH AND TINGLING DURING THE EXAM BUT CONTINUED THE EXAM. GE (THE MR SYSTEM MANUFACTURER) WAS NOTIFIED OF THE BURN BY THE MEDICAL FACILITY AND THEN THEY SUBSEQUENTLY NOTIFIED QED ON 05 MAR 2020.