BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3000

    MDR report key: 2021877 · Received February 25, 2011

    Report

    Report Number
    1720753-2011-01697
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP PERFORMED AN ON SITE INVESTIGATION AND RECOMMENDED THE CUSTOMER PURCHASE A NEW BATTERY. THE CUSTOMER IS MAKING A DECISION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM FAILED TO BOOT PROPERLY. 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