BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECAM/ESOFT

    MDR report key: 514292 · Received February 19, 2004

    Report

    Report Number
    MW1031312
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    February 8, 2004
    Report Date
    February 19, 2004
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNABLE TO CONFIGURE NETWORK WITH CONNECTED DEVICES AND UNABLE TO CORRECT TIME WITHIN SYNGO OPERATING SYSTEM WITHOUT A PASSWORD FROM MFR. THIS BLOCKS OWNER ABILITY TO PERFORM BASIC SYSTEM SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECAM/ESOFT NUCLEAR IMAGING IYX SIEMENS MEDICAL SOLUTIONS ESOFT *
    2 SYNGO PROCESSING SYSTEM IYX SIEMENS MEDICAL SOLUTIONS SYNGO *

    Patients

    Seq Age Sex Outcome Treatment
    1 *