BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA CAMERA

    MDR report key: 23681 · Received July 25, 1995

    Report

    Report Number
    MW1006558
    Event Type
    Malfunction
    Date Received
    July 25, 1995
    Report Date
    July 12, 1995
    Manufacturer
    SMV
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THERE IS NO PT TABLE ENCODING DEVICE ON THE END STAND HOLDERS TO ENABLE TRACKING OF THE PT TABLE. WITH THIS CURRENT CONDITION, THE POSSIBILITY EXISTS FOR THE END STANDS TO BECOME OUT OF SYNC AND THE TABLE CAN FALL OFF THE SYSTEM. THE MFR WAS NOTICED OF THIS PROBLEM LAST DECEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA CAMERA GAMMA CAMERA IYX SMV

    Patients

    Seq Age Sex Outcome Treatment
    1 *