BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXRADIN

    MDR report key: 469205 · Received May 27, 2003

    Report

    Report Number
    2184007-2003-00003
    Event Type
    Malfunction
    Date Received
    May 27, 2003
    Date of Event
    May 14, 2003
    Report Date
    May 22, 2003
    Manufacturer
    STANDARD IMAGING, INC.
    Product Code
    LHO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE EXRADIN A12 IONIZATION CHAMBER HAS A SIGNIFICANT DIFFERENCE IN THE CALIBRATION FACTOR FROM THAT PROVIDED ON THE CALIBRATION CERTIFICATE FROM THE ACCREDITED DOSIMETRY CALIBRATION LABORATORY (ADCL). THIS DEVICE IS USED FOR THE QUALITY ASSURANCE CHECKS ON RADIATION THERAPY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXRADIN IONIZATION CHAMBER LHO STANDARD IMAGING, INC. A12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *