BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL I 128

    MDR report key: 4096455 · Received September 12, 2014

    Report

    Report Number
    MW5038200
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ANN ARBOR DIGITAL DEVICES
    Product Code
    NVV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PODIATRY X-RAY MACHINER HAS BEEN MODIFIED BY A2D2 TO PRODUCT DIGITAL X-RAYS. THE MODIFICATION HAS CHANGED THE ORIGINAL MANUFACTURERS SID. THE CHANGE IN SID VIOLATES THE LIQUID DISTANCE BETWEEN X-RAY TUBE AND SUBJECT CAUSING AN INCREASE IN RADIATION EXPOSURE TO THE PATIENT. A CANNON REBEL T3I SLR CAMERA IS USED TO CAPTURE THE X-RAY IMAGE. HOW CAN THIS BE SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565144 MODEL I 128 MODEL I 128 NVV ANN ARBOR DIGITAL DEVICES A2D2 LOGO, MODEL I 128 PODIATRY

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other