BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRIS

    MDR report key: 584989 · Received March 23, 2005

    Report

    Report Number
    8030405-2005-00003
    Event Type
    Injury
    Date Received
    March 23, 2005
    Date of Event
    September 10, 2002
    Report Date
    March 22, 2005
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN MRI SCAN WITH THE HITACHI AIRIS DEVICE IN 2002. THE IMAGING CENTER REPORTED TO HITACHI MEDICAL SYSTEMS AMERICA, INC. ON 10/2002 THE PT COMPLAINED OF RINGING IN THE EARS. THE AIRIS HAS LOW POWER GRADIENTS THAT ARE NOT CAPABLE OF PRODUCING NOISE LEVELS ABOVE 99 DBA. THEREFORE, BASED UPON FDA GUIDANCE AND IEC 60601-2-33 STANDARDS, NO HEARING PROTECTION IS REQUIRED AT THESE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH HITACHI MEDICAL CORP. AIRIS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other