BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYTOM ELITE

    MDR report key: 19282293 · Received May 9, 2024

    Report

    Report Number
    3004938766-2024-00016
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 19, 2024
    Report Date
    May 9, 2024
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K170238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REQUIRED A RESCAN ON A DIFFERENT MACHINE AS THE BODYTOM ELITE SCANNER STOPPED MID-SCAN. WE HAVE IMPLEMENTED CORRECTIVE MEASURES TO MITIGATE THE RISK AND PREVENT ERRORS THROUGH SERVICE VISIT. DAIL CALIBRATION AND QUALITY ASSURANCE TESTING WAS COMPLETED ON THE SYSTEM WITH NO ISSUES. ANY ADDITIONAL INFORMATION RECEIVED ON THIS INCIDENT WILL BE REPORTED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    THE PATIENTS HAD RE-EXPOSURE DUE TO THE SCANNER STOPPING IN THE MIDDLE OF A SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358439 BODYTOM ELITE COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown