BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL IONIZING RADIATION PRODUCTS

    MDR report key: 2142462 · Received June 22, 2011

    Report

    Report Number
    MW5021119
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    KONICA MINOLTA MEDICAL IMAGING, INC.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FAILURE TO PROVIDE AIAT AND INSTALLER INSTRUCTIONS UPON REQUEST PURSUANT TO 21CFR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL IONIZING RADIATION PRODUCTS ALL IONIZING RADIATION PRODUCTS MQB KONICA MINOLTA MEDICAL IMAGING, INC. ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ALL IONIZING RADIATION PRODUCTS