BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA TWINSPEED EXCITE

    MDR report key: 1040080 · Received May 7, 2008

    Report

    Report Number
    2183553-2008-00021
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    October 5, 2003
    Report Date
    April 22, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K012200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND NO EVIDENCE OF DEFECTIVE EQUIPMENT OR SYSTEM MALFUNCTION THAT MIGHT HAVE CONTRIBUTED TO THE INCIDENT. ACCORDING TO THE FACILITY, HEARING PROTECTION WAS NOT USED DURING THE SCAN. SINCE ACOUSTIC LEVELS OF THE SYSTEM MAY EXCEED 99DBA IN THE BORE, HEARING PROTECTION IS REQUIRED FOR ALL PEOPLE IN THE MAGNET ROOM DURING A SCAN. THE SYSTEM'S OPERATOR MANUAL PROVIDES A WARNING OF THE ACOUSTIC LEVELS AS WELL AS INSTRUCTION TO USE ADEQUATE HEARING PROTECTION DURING A SCAN. THE FE EDUCATED THE SITE OF REQUIREMENTS OF PT EXPOSURE TO MR-GENERATED ACOUSTIC NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS SCANNED ON A 1.5T SIGNA TWINSPEED SYSTEM AND IS REPORTING TINNITUS AND HEARING LOSS. THE PT WAS SCANNED WITHOUT HEARING PROTECTION. SINCE THE INCIDENT, THE PT HAS BEEN EVALUATED BY A HEALTHCARE PROFESSIONAL AND MADE MULTIPLE VISITS TO THE DOCTOR FOR HEARING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA TWINSPEED EXCITE LNH GE MEDICAL SYSTEMS, LLC 2294302 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability