BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROMETRIC FETAL ECG CABLE

    MDR report key: 839173 · Received April 16, 2007

    Report

    Report Number
    839173
    Event Type
    Injury
    Date Received
    April 16, 2007
    Date of Event
    April 12, 2007
    Report Date
    April 15, 2007
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    KXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2007, BIOMED WAS CHECKING A FETAL ECG CABLE USED ON A LABORING PT. THE CABLE WAS FOUND TO NOT BE OPERATIONAL. FETAL BRADYCARDIA NOTED. BABY APGARS 1-3-3. BABY EXPIRED AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROMETRIC FETAL ECG CABLE FETAL ECG CABLE KXN GE MEDICAL SYSTEMS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening FETAL HEART MONITOR MODEL 259 A