BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA 3.0T HDX TWINSPEED

    MDR report key: 2026139 · Received March 17, 2011

    Report

    Report Number
    2183553-2011-00011
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 17, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE COMPLETED ACOUSTIC NOISE TESTING ON THE SYSTEM. THE MR SYSTEM IS WITHIN SPEC PER THE NEMA AND IEC STANDARDS FOR ACOUSTIC NOISE. THE MR SAFETY MANUAL 2381696-100, REV 11, STATES "WARNING HEARING PROTECTION IS REQUIRED FOR ALL PEOPLE, INCLUDING THE MR WORKER, IN THE MAGNET ROOM DURING A SCAN TO PREVENT HEARING IMPAIRMENT. ACOUSTIC LEVELS MAY EXCEED 99 DBA. PT HEARING PROTECTION WITH A NOISE REDUCTION RATING (NRR) OF 29 DB OR BETTER IS REQUIRED TO REDUCE ACOUSTIC LEVEL BELOW 99DBA. THE A-WEIGHTED RMS SOUND PRESSURE LEVEL IS MEASURED ACCORDING TO SECTION 26E AND 26G OF IEC 60601-2-33:2002." THE SITE PROVIDED HEARING PROTECTION TO THIS PT WITH A SNR VALUE OF 27 DB, WHICH CONVERTS TO A NRR VALUE OF 23 DB. FOLLOWING THE EVENT, HEARING PROTECTION WAS CHANGED BY THE SITE PER GE HEALTHCARE'S RECOMMENDATION TO A 3M MODEL 1100 WITH A SNR VALUE OF 37 DB, WHICH CONVERTS TO A NRR VALUE OF 33 DB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS DIAGNOSED WITH HEARING LOSS AFTER A MR HEAD SCAN. THE PT IS REPORTEDLY UNDER THE CARE OF A PHYSICIAN, AND WAS PRESCRIBED A CORTICOID. THE SCAN REPORTEDLY LASTED APPROX 23 MINUTES, AND THE PT WAS PROVIDED WITH HEARING PROTECTION WITH A SNR (SINGLE NUMBER RATING) VALUE OF 27 DB (DECIBELS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA 3.0T HDX TWINSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 5308573-2

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other