BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTSTAT

    MDR report key: 2153501 · Received June 21, 2011

    Report

    Report Number
    1720753-2011-08391
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER TO REBUILD THE PATIENT DATABASE WHICH IMPROVED ACCESSIBILITY BUT VIEWING THE IMAGES WAS STILL AN ISSUE. THE PATIENT DATABASE DIRECTORY WAS DELETED. A SHUTDOWN FROM THE MAIN MENU WAS PERFORMED AND THE SYSTEM WAS REBOOTED. 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 WOULD NOT ALLOW ADEQUATE ACCESS TO THE PATIENT FILES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTSTAT MEDICAL IMAGE COMMUNICATIONS DEVICE JAA GE OEC MEDICAL SYSTEMS (SLC) CONNECTSTAT

    Patients

    Seq Age Sex Outcome Treatment
    1