BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA ARTIST 96

    MDR report key: 20643359 · Received November 8, 2024

    Report

    Report Number
    3010949642-2024-00006
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    January 10, 2022
    Report Date
    January 16, 2025
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    UDI-DI
    00840682123129
    PMA / PMN Number
    K163331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE (GEHC) HAS CONCLUDED ITS INVESTIGATION. A REVIEW OF SYSTEM SERVICE RECORDS CONFIRMS THAT THE MR SYSTEM WAS OPERATING WITHIN SPECIFICATIONS, WITH NO IDENTIFIED ISSUES OR DEFECTS. BASED ON THE AVAILABLE INFORMATION, NO APPARENT ROOT CAUSE FOR THE PATIENT INJURY HAS BEEN DETERMINED. RF WARMING CAN OCCUR DUE TO THE COUPLING WITH HIGH-POWER RADIOFREQUENCY TRANSMISSIONS OF AN MR SCANNER DURING NORMAL CLINICAL USE, EVEN WHILE OPERATING WITHIN SPECIFICATIONS. THE OPERATOR MANUAL INCLUDES WARNINGS ABOUT TISSUE HEATING, EVEN WHEN GOOD CLINICAL PRACTICES AND PROPER RF PADDING ARE FOLLOWED. GEHC DOES NOT PLAN ANY FURTHER ACTIONS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. G2: (B)(6). H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FELT "INTENSE AND STRONG HEAT" ON THEIR RIGHT SIDE DURING A MR EXAMINATION OF THE RIGHT SHOULDER. THERE IS NO REPORT OF A BURN OR OTHER TYPICAL SIGN OF SIGNIFICANT RF-RELATED INJURY. THIS EVENT WAS INITIALLY ASSESSED AS NOT REPORTABLE AS WARMING DURING AN MR EXAM MAY OCCUR DUE TO THE RF ENERGY, AND TYPICALLY RESULTS IN MINOR DISCOMFORT WHICH IS SELF-RESOLVING. SUBSEQUENTLY, THE GE HEALTHCARE COMPLAINT HANDLING UNIT BECAME AWARE OF ADDITIONAL INFORMATION FROM THE PATIENT THAT DESCRIBES ONGOING PAIN THAT REQUIRES PAIN MEDICATION; THEREFORE, WE HAVE UPDATED OUR ASSESSMENT TO A SERIOUS INJURY. THE CAUSE OR SOURCE OF THE ONGOING PAIN HAS NOT BEEN CLEARLY IDENTIFIED. BASED ON THE SERVICE AND PREVENTATIVE MAINTENANCE RECORDS THAT WE HAVE REVIEWED FOR THE SYSTEM FROM THE TIME OF THE EVENT UNTIL NOW, WE DO NOT HAVE ANY EVIDENCE THAT THE SYSTEM MALFUNCTIONED, HOWEVER OUR INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111711 1.5T SIGNA ARTIST 96 NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA ARTIST 00840682123129

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other