BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT SCANNER

    MDR report key: 8460122 · Received March 27, 2019

    Report

    Report Number
    MW5085276
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 13, 2019
    Report Date
    March 25, 2019
    Manufacturer
    GE HEALTHCARE (GE MEDICAL SYSTEM, LLC)
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT CT SCAN IMAGING AND ARTIFACT WAS NOTED. THE ELECTRONIC BOARD FOR THE DETECTOR WAS RESEATED. CT SCANNER PLACED BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247924 CT SCANNER SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK GE HEALTHCARE (GE MEDICAL SYSTEM, LLC) VCT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR