BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTAIRE

    MDR report key: 584978 · Received March 23, 2005

    Report

    Report Number
    8030405-2005-00001
    Event Type
    Injury
    Date Received
    March 23, 2005
    Date of Event
    August 26, 2002
    Report Date
    March 22, 2005
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN MRI SCAN WITH THE HITACHI ALAIRE DEVICE IN 2002. THE IMAGING CENTER REPORTED TO HITACHI MEDICAL SYSTEMS AMERICA, INC. IN 10/2002 THE PT COMPLAINED OF TINNITUS. HEARING PROTECTION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other