BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP XW5000 WORKSTATION

    MDR report key: 602405 · Received August 5, 2004

    Report

    Report Number
    9613299-2004-00009
    Event Type
    Malfunction
    Date Received
    August 5, 2004
    Date of Event
    March 31, 2004
    Report Date
    August 5, 2004
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    KPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MYOVATION BASED RECONSTRUCTION PROGRAMS ON THE XELERIS WORKSTATIONS INTEMITTENTLY AND UNINTENTIONALLY APPEAR DIFFERENT IN THE STATIC VERSUS THE DYNAMIC/GATED MODES. ROOT CAUSE INVESTIGATION DETERMINED THE CAUSE TO BE SOFTWARE ISSUE ASSOCIATED WITH THE X-DIRECTION THE CAUSE TO BE A SOFTWARE ISSUE ASSOCCIATED WITH THE X-DIRECTION MOTION CORRECTION DURING DATA REPROCESSING OF THE SAME STUDY SESSION IN SPECT CARDIOLOGY APPLICATIONS. THE GATED RESULTS ARE AFFECTED; PERFUSION RESULTS ARE NOT. THE CONCERN IS FOR PATIENT MISDIAGNOSIS AND UNWANTED CATHERIZATION. USE REPORTS THAT ONE PATIENT MAY HAVE BEEN MISDIAGNOSED. NO OTHER INJURIES OR OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HP XW5000 WORKSTATION NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS F.I. HAIFA 2372897 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other