BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX-REVOLUTION

    MDR report key: 3030044 · Received March 28, 2013

    Report

    Report Number
    3030044
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AROUND 0445 A RETROGRADE URETHROGRAM WAS PERFORMED AT THE BEDSIDE. A RADIATION EXPOSURE WAS MADE WHILE THE CONTRAST WAS BEING PUSHED INTO THE PATIENT BY THE DR. MY IMAGE APPEARED AS THE DR. AND MYSELF LOOKED AT IT CLEARLY. AFTER THE UNIT REPROCESSED, THE IMAGE WAS NON-DIAGNOSTIC. THE ALGORITHM WAS UNADJUSTABLE. EVERY ATTEMPT AT BRINGING THE IMAGE BACK WAS MADE. FINALLY, ANOTHER INJECTION OF CONTRAST WAS MADE INTO THE PATIENT AND ANOTHER IMAGE WAS TAKEN. THE PORTABLE UNIT (DR3) WAS CALLED INTO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127783 DRX-REVOLUTION SYSTEM, X-RAY, MOBILE IZL CARESTREAM HEALTH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR