BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE

    MDR report key: 1834546 · Received September 6, 2010

    Report

    Report Number
    1834546
    Event Type
    Malfunction
    Date Received
    September 6, 2010
    Date of Event
    April 27, 2010
    Report Date
    September 6, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMAGES WERE BEING LOST IN THE PACS SYSTEM DUE TO DATABASE NOT SYNCING PROPERLY. THIS HAS HAPPENED ON MORE THAN ONE OCCASION. WHAT SIEMENS HAS FOUND IS THE FILES WERE CORRUPT, SO THAT YOU CAN'T FIND THEM. IN SOME CASES, OR YOU CAN FIND THEM, BUT YOU CAN'T DO ANYTHING WITH THE IMAGES, SUCH AS SEND THEM TO THE PACS UNIT. SIEMENS DID TAKE IMAGES FROM THE HARD DRIVE AND SEND THEM TO GERMANY FOR EVALUATION. THEY CAME BACK WITH INTERNAL SYNC ERRORS CAUSING THE PROBLEM. SOMETHING WAS HAPPENING TO THE IMAGES DURING TRANSFER. A SOFTWARE UPDATE WAS INSTALLED AND IS SUPPOSED TO FIX THAT. TO OUR KNOWLEDGE THERE HAVE BEEN NO MORE SYNC ERRORS SINCE THE UPGRADE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIS ZEE X-RAY SYSTEM, CATH/ANGIO, BIPLANE JAA SIEMENS MEDICAL SOLUTIONS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *