BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3500L

    MDR report key: 1992811 · Received February 4, 2011

    Report

    Report Number
    1720753-2011-00917
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 4, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP CONTACTED THE CUSTOMER AND DIRECTED HIM IN EVALUATING THE SYSTEM, BUT NO RESULTS OR SYSTEM REPAIR STATUS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WILL NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1