BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLX M25.16 SW PACKAGE

    MDR report key: 635521 · Received September 15, 2005

    Report

    Report Number
    9611343-2005-00030
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Date of Event
    August 28, 2005
    Report Date
    September 15, 2005
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FROM GE INTERNAL ENGINEERING TESTING THAT AFTER A 1024 DSA QUANTITATIVE CARDIAC ANALYSIS (QCA) CALIBRATION IS COMPLETE, THE CALIBRATION FACTOR IS EXTENDED TO A 512 QUANTITATIVE VENTRICULAR ANALYSIS (QVA) SEQUENCE. THIS CREATES A WRONG CALIBRATION FACTOR FOR THE 512 QVA. NO PT WAS INVLOVED AND NO INJURIES WERE REPORTED. THE CONCERN IS FOR POSSIBLE PT INJURY OR MISDIAGNOSIS CAUSED BY ERRONEOUS MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLX M25.16 SW PACKAGE DIAGNOSTIC X-RAY IZI GE MEDICAL SYSTEMS SCS 2371665 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *