BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 25172699 · Received May 13, 2026

    Report

    Report Number
    MW5188200
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Report Date
    May 8, 2026
    Manufacturer
    UNKNOWN
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    S7 - CANNOT RECEIVE THE IMAGE FROM THE C-ARM. 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
    353601 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1