BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAK 8000 PANORAMIC SYSTEM

    MDR report key: 7864129 · Received September 11, 2018

    Report

    Report Number
    7864129
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 31, 2017
    Report Date
    August 7, 2018
    Manufacturer
    CARESTREAM DENTAL LLC
    Product Code
    MUH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PANOREX X-RAY ORDERED BY THE ER PHYSICIAN. THE IMAGE DISAPPEARED FROM THE SCREEN AND COULD NOT BE RETRIEVED. A CT SCAN OF THE FACIAL BONES HAD TO BE ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705442 KODAK 8000 PANORAMIC SYSTEM SYSTEM,X-RAY,EXTRAORAL SOURCE,DIGITAL MUH CARESTREAM DENTAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA