BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3000

    MDR report key: 1992804 · Received February 4, 2011

    Report

    Report Number
    1720753-2011-00916
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    November 5, 2010
    Report Date
    February 4, 2011
    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

    NO GE SERVICE PERFORMED, CUSTOMER DID NOT APPROVE REPAIR QUOTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    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