BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS MEDICAL SOLUTIONS USA, INC.

    MDR report key: 541709 · Received June 23, 2004

    Report

    Report Number
    MW1032633
    Event Type
    Malfunction
    Date Received
    June 23, 2004
    Date of Event
    June 12, 2004
    Report Date
    June 18, 2004
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING A LOWER PERIPHERAL ANGIOGRAPH. AFTER THE FIRST INJECTION SERIES (60CC) THE ENTIRE IMAGE REVIEW WAS LOST AND THE SYSTEM ERROR WAS "BYPASS FLUORO." THE X-RAY SYSTEM WAS REBOOTED AND THE PT WAS INJECTED FOR THE SECOND TIME (EXPOSING THE PT TO MORE X-RAY AND DYE). TWO DAYS LATER IT WAS NOTED THAT THE PT NAME HAD BEEN MISSPELLED (MEDICAL RECORD # AND BIRTHDATE CORRECT) WHICH CAUSED THE FILE TO BE CORRUPTED AND THE FIRST INJECTION RUN COULD NOT BE RETRIEVED. THERE APPEARS TO BE NO FLAG TO INDICATE AN INCORRECT ENTRY HAS OCCURRED IN THE EXISTING PT DEMOGRAPHICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS MEDICAL SOLUTIONS USA, INC. AXIUM ARTIS FA-ANGIOGRAPHIC SYSTEM IZI SIEMENS MEDICAL SOLUTIONS USA AXIUM ARTIS FA *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other