BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE 2 DISPLAY SYSTEM

    MDR report key: 22633358 · Received July 28, 2025

    Report

    Report Number
    MW5173428
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Report Date
    July 1, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE (B)(6) AZURE 2 DISPLAY SYSTEM, CHANGES FROM THE CARTO 16X9 ASPECT RATIO 1920X1080P "WINDOW PANE" TO THEN 'DRAW' THE LS PRO'S 4X3 ASPECT RATIO 1600X1200 P "WINDOW PANE", THE VIDEO PROCESSING SYSTEM WAS HAVING TROUBLE WITH TRANSITIONING BETWEEN THE TWO DIFFERENT ASPECT RATIOS AND RESOLUTIONS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107363 AZURE 2 DISPLAY SYSTEM SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown