BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 3500

    MDR report key: 2943200 · Received January 21, 2013

    Report

    Report Number
    1720753-2013-00851
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 21, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND PLACED A TRANSMITTER CABLE ON ORDER, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PINS WITHIN THE TRANSMITTER CABLE WERE DAMAGED RESULTING IN A COMPLETE LOSS OF NAVIGATION FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28978 ITRAK 3500 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1