BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE 8 SLICE CT SCANNER

    MDR report key: 3223777 · Received June 12, 2013

    Report

    Report Number
    3223777
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    G.E. HEALTHCARE
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN SCANNED A CT OF CHEST SCANNER; ERROR DURING SCANNING. PATIENT REMOVED FROM SCANNER AND SCANNER WAS SHUT DOWN RE-BOOTED AND THE PATIENT WAS SCANNED A SECOND TIME.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265056 GE 8 SLICE CT SCANNER SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK G.E. HEALTHCARE 215952ISU *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR