BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETAL MONITOR

    MDR report key: 17273 · Received October 28, 1994

    Report

    Report Number
    MW1003855
    Event Type
    Malfunction
    Date Received
    October 28, 1994
    Date of Event
    October 11, 1994
    Report Date
    October 20, 1994
    Manufacturer
    COROMETRIC MEDICAL SYSTEMS, INC.
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MONITOR POSSIBLY CONTRIBUTED TO PROLONGED HOSPITALIZATION. MOTHER WITH HIGH RISK DUE TO PREECLAMPSIA, WAS ON PITOCIN AND MGSO4 IV'S ONGOING. EXTERNAL FETAL MONITOR INDICATED DECELERATIONS. IUPC PLACED ON AND IUPC CABLE SWITCHES NOT CONNECTING WELL, ADJUSTED, EPIDURAL PLACEMENT DONE; MACHINE APPEARED TO BE SKIPPING WHEN MARKING FHR. EXTERNAL MONITOR REAPPLIED AND DIFFERENT FHR OBTAINED; NURSING INTERVENTIONS PERFORMED DUE TO FHR. A SECOND INTERNAL MONITORING UNIT WAS OBTAINED AND NON-REASSURING FHR WAS CONFIRMED; C-SECTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR FETAL MONITOR KXN COROMETRIC MEDICAL SYSTEMS, INC. 115

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other