BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGNA EXPLORER

    MDR report key: 22862010 · Received August 21, 2025

    Report

    Report Number
    3010949642-2025-00004
    Event Type
    Death
    Date Received
    August 21, 2025
    Report Date
    November 11, 2025
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2, 6. THIS FOLLOW-UP REPORT IS SUBMITTED TO CORRECT THE INITIAL SUBMISSION. BASED ON THE INFORMATION AVAILABLE TO GE HEALTHCARE (GEHC) AT THIS TIME, IT HAS BEEN DETERMINED THAT THE GEHC MR DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, AND NO DEVICE MALFUNCTION OCCURRED. THEREFORE, THIS EVENT DOES NOT MEET THE CRITERIA FOR MANDATORY REPORTING UNDER 21 CFR PART 803.

    Additional Manufacturer Narrative · 0

    A1, 4, 5, 6: NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED TO GE HEALTHCARE (GEHC). B2, 3: INFORMATION WAS NOT PROVIDED TO GEHC. D: NO ADDITIONAL DEVICE IDENTIFICATION INFORMATION WAS PROVIDED TO GEHC. G2: REPORT SOURCE OTHER, KOREAN NATIONAL POLICE AGENCY. H4: NO DEVICE INFORMATION WAS PROVIDED TO GEHC TO IDENTIFY DATE OF MANUFACTURE. H6: GEHC'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. GEHC HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THE REPORT SOURCE.

    Description of Event or Problem · 0

    GE HEALTHCARE (GEHC) WAS CONTACTED BY LOCAL AUTHORITIES TO SUPPORT THEIR INVESTIGATION INTO A PATIENT DEATH FOLLOWING A CARDIAC ARREST DURING AN MRI SCAN INVOLVING A GEHC MR SYSTEM. WHILE GEHC HAS LIMITED INFORMATION AT THIS TIME, THE INITIAL REPORT INDICATES THE INCIDENT IS NOT CONSIDERED TO BE RELATED TO THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466293 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death