BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 3792309 · Received January 10, 2014

    Report

    Report Number
    1720753-2014-00386
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    December 27, 2013
    Report Date
    January 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE AND DIRECTED THEM IN REPAIRING THE SYSTEM. THE CUSTOMER PERFORMED A DATABASE RECOVERY, AND REMOVED PATIENT DATA FROM PREVIOUS YEARS FROM THE SYSTEM. IT WAS RECOMMENDED THAT THE CUSTOMER KEEP DATA ON THE SYSTEM FOR SIX MONTHS. THE SYSTEM OPERATES AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP. THIS RESULTED IN A TOTAL LOSS OF NAVIGATION FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20566 INSTATRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) INSTATRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1