BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTSTAT

    MDR report key: 2191140 · Received July 19, 2011

    Report

    Report Number
    1720753-2011-20208
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REP REBUILT THE PT DATABASE, AND REPAIRED THE HARD DRIVE. 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 LOCK UP. NO PT 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