FDA Adverse Event Injury Summary report: N

GE SIGNA ARTIST ¿ 1.5 TESLA

MDR report key: 23015345 · Received September 10, 2025

Report

Report Number
MW5175809
Event Type
Injury
Date Received
September 10, 2025
Date of Event
August 7, 2025
Report Date
September 4, 2025
Manufacturer
GE HEALTHCARE MANUFACTURING LLC
Product Code
LNH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE PATIENT WAS HAVING A DIAGNOSTIC MRI PROCEDURE IN THE OUTPATIENT SETTING TO EVALUATE A TORN LEFT BICEP UTILIZING A FLEX COIL PAD THAT WAS WRAPPED AROUND HIS LEFT BICEP FOR FOCAL IMAGING PURPOSES OF LATTER ANATOMICAL AREA. ALL MRI SAFETY PROCEDURES WERE FOLLOWED INCLUDING PATIENT SCREENING, WANDING, AND THE USE OF PADDING BETWEEN THE PATIENT AND THE MAGNET DURING THE DIAGNOSTIC PROCEDURE. THE PATIENT WAS OBSERVED, AND VERBAL CHECK-INS OCCURRED THROUGHOUT THE PROCEDURE; HE DID NOT REPORT ANY CONCERNS DURING THE PROCEDURE. POST PROCEDURE, TWO CLOSED BURN WOUNDS WERE IDENTIFIED ON THE PATIENT - ONE TO THE PATIENT'S LEFT BICEP AND THE SECOND ONE TO HIS RIGHT-HAND MIDDLE KNUCKLE. THE PATIENT REPORTED AFTER THE PROCEDURE FEELING IMMEDIATE HEAT AND A SHOCK AT THE START OF THE PROCEDURE TO HIS LEFT UPPER ARM THAT IMMEDIATELY RESOLVED WHEN HE MOVED HIS RIGHT ARM AWAY FROM HIS LEFT ARM. THE PATIENT'S RATIONALE FOR NOT REPORTING THE HEAT/SHOCK TO THE TECHNOLOGIST AT THE OCCURRENCE TIME WAS THAT THE ISSUE IMMEDIATELY RESOLVED AND HE DID NOT WANT TO HAVE TO GO THROUGH THE PROCEDURE AGAIN. THE PATIENT RECEIVED A FOLLOW UP EVALUATION IN THE EMERGENCY DEPARTMENT FOR THE TWO BURN WOUNDS. AFTER THE EVENT, THE ENGINEERING TEAM INSPECTED/TESTED THE MRI SYSTEM TO VALIDATE IT WAS OPERATING AS INTENDED WITH NO FUNCTIONAL ISSUES IDENTIFIED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2499443 GE SIGNA ARTIST ¿ 1.5 TESLA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC GE SIGNA ARTIST ¿ 1.5 TESLA

Patients

Seq Age Sex Outcome Treatment
1 38 YR Male Other