BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3500

    MDR report key: 3252661 · Received July 25, 2013

    Report

    Report Number
    1720753-2013-08536
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 25, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE COMPUTER. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAV PC WOULD NOT BOOT WHEN SYS WAS TURNED ON (NO BOOT). 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
    348768 ITRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1