BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DBC

    MDR report key: 866090 · Received May 30, 2007

    Report

    Report Number
    866090
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    April 19, 2007
    Report Date
    May 30, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PROCEDURE WAS INTERRUPTED DUE TO EQUIPMENT FAILURE. UNABLE TO OBTAIN FLUOROSCOPY IMAGES. X-RAY SYSTEM REBOOTED. SIEMENS TECHNICIAN AND BIOMED STAFF ON HAND BUT UNABLE TO RESOLVE PROBLEM. PATIENT TRANSPORTED TO NEW ROOM TO RESUME PROCEDURE. PATIENT WAS IN NO APPARENT DISTRESS. VITAL SIGNS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS DBC X-RAY SYSTEM KPR SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 7728392 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR