BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 22687794 · Received August 1, 2025

    Report

    Report Number
    2183553-2025-00013
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    June 19, 2025
    Report Date
    September 18, 2025
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K160621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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. A1: PATIENT ID HAS NOT BEEN PROVIDED TO GE HEALTHCARE (GEHC). D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. 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

    B4; G1, 3, 6; H2, 3, 6. 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 THAT A PATIENT WHO UNDERWENT AN MRI OF THE SPINE SUBSEQUENTLY SOUGHT EVALUATION BY AN ENT SPECIALIST DUE TO HEARING CONCERNS. THE PATIENT WAS DIAGNOSED WITH HEARING LOSS AND TREATED WITH MEDICATIONS. AT THIS TIME, IT IS UNKNOWN WHETHER THE PATIENT'S CONDITION HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223589 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC SIGNA PIONEER

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other