BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS DIACAM

    MDR report key: 515155 · Received February 27, 2004

    Report

    Report Number
    MW1031326
    Event Type
    Malfunction
    Date Received
    February 27, 2004
    Date of Event
    October 15, 2003
    Report Date
    February 26, 2004
    Manufacturer
    SIEMENS,
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    STARTING OCT 3 REPORTER HAS BEEN FIGHTING SIEMENS TO GET SOMEONE HERE TO REPAIR FACILITY'S NUCLEAR MED CAMERA. AT THAT TIME, FACILITY CALLED IN A PROBLEM WITH POOR FLOOD RESULTS. IT WAS DETERMINED THAT THE PROBLEM WAS RELATED TO THE X-Y COORDINATES ON THE FLOOD. SIEMENS UPTIME WAS CONTACTED IN OCT 2003. ON THIS OCCASION THERE WHERE 3 MISSED SERVICE APPOINTMENTS, 9 DOWN DAYS, AND 5 SEPARATE SERVICE VISITS BEFORE FACILITY WAS UP AND RUNNING. FACILITY AGAIN HAD A POOR FLOOD PROBLEM IN 2004 (JUST 4 MONTHS AFTER THE PREVIOUS PROBLEM). THIS TIME IT APPEARED THAT THE SIEMENS SERVICE PEOPLE WERE READING FROM A SCRIPT FROM THE PREVIOUS SERVICE CALL. FACILITY AGAIN HAD SEVERAL MISSED APPOINTMENTS FROM SIEMENS SERVICE PERSONNEL, AND FACILITY IS NOW AT THE TIME OF THIS LETTER, AT 23 DOWN DAYS AND COUNTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS DIACAM NUCLEAR MEDICINE CAMERA IYX SIEMENS, HD3 INTIGRATED *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other