BEUDAMED
    FDA Adverse Event Other Summary report: N

    HITACHI ALTAIRE HIGH-FIELD PERFORMANCE

    MDR report key: 503359 · Received December 12, 2003

    Report

    Report Number
    MW1030590
    Event Type
    Other
    Date Received
    December 12, 2003
    Date of Event
    August 26, 2002
    Report Date
    November 14, 2003
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2002, PT UNDERWENT A BRAINSTEM MRI ON THE HITACHI ALTAIRE HIGH-FIELD PERFORMANCE OPEN MRI MACHINE. PT WAS GIVEN A SET OF HEADPHONES TO LISTEN TO A CD WHILE BEING SCANNED. THE NOISE LEVEL WAS INTOLERABLE EVEN WITH THE HEADPHONES. THE SCAN LASTED APPROX ONE HOUR. PT LEFT THE MRI FACILITY WITH SEVERE FULLNESS IN RIGHT EAR AND BILAT. TINNITUS. THE FULLNESS HAS IMPROVED BUT THE TINNITUS IS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI ALTAIRE HIGH-FIELD PERFORMANCE OPEN MRI MACHINE LNH HITACHI MEDICAL SYSTEMS AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other