BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3500

    MDR report key: 3980178 · Received July 2, 2014

    Report

    Report Number
    1720753-2014-05620
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COMPUTER WAS EVALUATED AND REPLACED. THE SYS SOFTWARE WAS RELOADED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FIELD ENGINEER NOTED THAT THE COMPUTER WOULD NOT BOOT UP. THIS RESULTED IN A LOSS OF NAVIGATION FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387983 ITRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1