BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTA TRAK 3500

    MDR report key: 2100246 · Received May 16, 2011

    Report

    Report Number
    1720753-2011-07362
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 16, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED TO REPLACE THE RECEIVER CABLE, AND RELOAD THE PT SCAN, AND THE TRACKER SHOWED ACTIVE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A TRACKING ERROR MESSAGE AND THAT THE MENU DISPLAYED THAT THE TRACKING WAS INACTIVE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1