BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 2100838 · Received May 12, 2011

    Report

    Report Number
    1720753-2011-07295
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP INSTRUCTED THE CUSTOMER OVER THE PHONE TO PERFORM MANUAL REGISTRATION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PERFORM TRACKING. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1