BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DST

    MDR report key: 218939 · Received April 14, 1999

    Report

    Report Number
    9615727-1999-00001
    Event Type
    Malfunction
    Date Received
    April 14, 1999
    Date of Event
    February 4, 1999
    Report Date
    February 16, 1999
    Manufacturer
    SMV INTERNATIONAL
    Product Code
    IYX
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GANTRY LEANING SLIGHTLY WITH HEAD ONE ON THE TOP AND HEAD TWO ON THE BOTTOM. INVESTIGATION MADE BY "F/S" DURING PREVENTIVE MAINTENANCE BY MEANS OF A LASER BEAM AND "COR" TESTS, AND A CLICKING SOUND FROM THE ROTATION LET THE "F/S" STOP THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST GAMMACAMERA IYX SMV INTERNATIONAL DST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *