BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT SIMULATOR

    MDR report key: 22809862 · Received August 14, 2025

    Report

    Report Number
    MW5174576
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 11, 2025
    Manufacturer
    PHILLIPS ULTRASOUND LLC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CT SIMULATOR WOULD NOT POWER ON. CONTACTOR DAMAGED TO POWER SUPPLY. NEW PART ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788690 CT SIMULATOR SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILLIPS ULTRASOUND LLC SN 7035

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male