BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO

    MDR report key: 3861317 · Received April 23, 2014

    Report

    Report Number
    3861317
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 23, 2014
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246113 CIC PRO PHYSIOLOGICAL MONITORING CENTRAL STATION MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. * *
    246114 SOLAR 8000I PHYSIOLOGICAL MONITORING BEDSIDE MONITOR MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. * *
    246115 RAC 4A PHYSIOLOGICAL MONITORING TRAM RACK MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. * *
    246116 450SL PHYSIOLOGICAL MONITORING TRAM MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *