BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC

    MDR report key: 7548987 · Received May 25, 2018

    Report

    Report Number
    MW5077469
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 23, 2018
    Manufacturer
    KONICA MINOLTA, INC.
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KONICA READER SHUT DOWN DUE TO HARD DRIVE FAILURE. RADIOLOGY IMAGES LOST. PATIENT NEEDED IMAGES RETAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389292 RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC IWZ KONICA MINOLTA, INC. CS-3

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR