BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDR

    MDR report key: 7144102 · Received December 22, 2017

    Report

    Report Number
    1220984-2017-00272
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 29, 2017
    Report Date
    November 29, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KGI
    PMA / PMN Number
    KO23398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE GETTING HORIZONTAL LINES IN THE IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. THE FE PERFORMED THE APERTURE CALIBRATION, ONCE THIS WAS DONE, THE UNIT IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922660 QDR DENSITOMETER, BONE KGI HOLOGIC, INC. RM-QDR-4500C N/A

    Patients

    Seq Age Sex Outcome Treatment
    1