BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3000

    MDR report key: 2850632 · Received November 27, 2012

    Report

    Report Number
    1720753-2012-09676
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE UPS, BATTERY AND IFB BOARD WERE 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 COMPLETELY BOOT UP. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITRAK 3000 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3000

    Patients

    Seq Age Sex Outcome Treatment
    1