BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADSPEED PRO

    MDR report key: 9213727 · Received October 18, 2019

    Report

    Report Number
    MW5090483
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    August 21, 2019
    Report Date
    October 2, 2019
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THIS OCCURRED ON A GENERAL RAD ROOM. DIGITAL PT IMAGES WERE LOST DUE TO SOFTWARE CORRUPTION. NEW SOFTWARE WAS LOADED, WASN'T REALIZED TILL AFTER THE SITE TRIED TO TAKE PT IMAGES THAT THE NETWORKING WASN'T WORKING. (B)(6) SOFTWARE WAS UPDATED WHICH CORRUPTED THE MEDICAL X-RAY IMAGES CAUSING THEM TO BE UNRECOVERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004947 RADSPEED PRO SYSTEM, X-RAY, STATIONARY KPR SHIMADZU MEDICAL SYSTEMS RADSPEED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR