BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (QS) COROMETRICS/GE MEDICAL

    MDR report key: 361235 · Received November 5, 2001

    Report

    Report Number
    361235
    Event Type
    Injury
    Date Received
    November 5, 2001
    Date of Event
    October 18, 2001
    Report Date
    November 2, 2001
    Manufacturer
    G.E. MEDICAL SYSTEMS, INFO TECH SYSTEMS
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LABOR, MONITOR ALARM WAS MANUALLY DEACTIVATED. UPON AN EVENT OF A DECREASING FHR, ALARM DID NOT SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49362 (QS) COROMETRICS/GE MEDICAL FETAL MONITORING SURVEILLANCE AND CHARTING KXN G.E. MEDICAL SYSTEMS, INFO TECH SYSTEMS Q.S. (QUANTITATIVE SENTINE) *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| O