BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROMETRICS

    MDR report key: 507977 · Received December 31, 2003

    Report

    Report Number
    2124823-2003-00083
    Event Type
    Malfunction
    Date Received
    December 31, 2003
    Date of Event
    July 30, 2003
    Report Date
    December 30, 2003
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    KNG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROMETRICS FETAL MONITOR KNG GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 118 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR