BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETAL MONITOR 118

    MDR report key: 508379 · Received October 17, 2003

    Report

    Report Number
    508379
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    July 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    GE MEDICAL SYSTEMS INFO TECHNOLOGIES
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR 118 FETAL MONITOR KXN GE MEDICAL SYSTEMS INFO TECHNOLOGIES 118 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other