BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 2081927 · Received April 5, 2011

    Report

    Report Number
    1720753-2011-03259
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 25, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE COMPUTER AND THE MONITOR WERE REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 3500 SYSTEM WOULD NOT BOOT UP. 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) INSTATRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1