BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 3.0T SIGNA HDX MR SYSTEM

    MDR report key: 21663353 · Received March 21, 2025

    Report

    Report Number
    2183553-2025-00003
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    December 4, 2024
    Report Date
    May 15, 2025
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS MR - 3200 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188. D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. D4: PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED. AN ACOUSTIC PERFORMANCE TEST WAS PERFORMED PER NEMA STANDARDS PUBLICATION NO. MS4-2010 (ACOUSTIC NOISE MEASUREMENT PROCEDURE FOR DIAGNOSTIC MAGNETIC RESONANCE IMAGING DEVICES) AND IEC/CEI 60601-2-33 CLAUSE 26. THE TESTING CONCLUDES THAT THE SYSTEM IS WITHIN THE SPECIFICATION FOR THIS SYSTEM CONFIGURATION. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S). THE PATIENT WAS PROVIDED PROPER HEARING PROTECTION DURING THE SCAN. HUMAN CONDITIONS MAY CAUSE SENSITIVITY TO ACOUSTIC LEVELS THAT OCCUR DURING NORMAL CLINICAL SCANNING. NO SYSTEM ISSUE WAS FOUND. NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT THAT UNDERWENT AN MRI EXAM OF THE LUMBAR SPINE COMPLAINED OF HEARING LOSS. THE PATIENT WAS REPORTED TO HAVE BEEN EVALUATED BY AN AUDIOLOGIST AND DETERMINED TO HAVE HEARING LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545976 GE 3.0T SIGNA HDX MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other