BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3500

    MDR report key: 3000999 · Received February 27, 2013

    Report

    Report Number
    1720753-2013-03171
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 27, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE CMOS BATTERY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84120 ITRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1