BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS MEDICAL SOLUTIONS USA, INC.

    MDR report key: 511268 · Received February 6, 2004

    Report

    Report Number
    MW1031065
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    January 2, 2004
    Report Date
    January 21, 2004
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, I
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING AN AORTIC ARCH AND BILATERAL CAROTID ANGIOGRAM AND THE SYSTEM GAVE A MESSEGE "BYPASS FLUORO AND IMAGE PROCESSING NOT AVAILABLE." THE CATHETER HAD TO BE REMOVED FROM THE PT SO THAT THE SYSTEM COULD BE REBOOTED (TAKES ATLEAST 7 MINUTES). AFTER THE INJECTION THE SAME ERROR OCCURRED (SYSTEM RECOVERED ON ITS OWN) AND RESULTED IN THAT THE RIGHT OBLIQUE IMAGE FILE WAS CORRUPT AND HARD COPIES COULD NOT BE OBTAINED. THE FLUORO BY-PASS ERROR IS NOT AN ISOLATED EVENT AND HAS NOT BEEN CORRECTED BY THE VENDOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other