BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS 128 EDGE DUAL ENERGY

    MDR report key: 9140558 · Received September 30, 2019

    Report

    Report Number
    MW5090119
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 27, 2019
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    CT SCANNER WOULD NOT REBOOT AFTER TECH SHUT EQUIPMENT DOWN FOR DAILY QA. UNABLE TO COMPLETE SCANS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926945 SIEMENS 128 EDGE DUAL ENERGY SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability