BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3500

    MDR report key: 2833586 · Received October 29, 2012

    Report

    Report Number
    1720753-2012-08780
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 29, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CMOS BATTERY WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1