BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRONIC FETAL MONITOR COROMETRICS ELECTRONIC FETAL MONITOR

    MDR report key: 7373008 · Received March 26, 2018

    Report

    Report Number
    MW5076124
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 11, 2018
    Report Date
    March 23, 2018
    Manufacturer
    GE HEALTHCARE
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE GE EFM 259CX-D MULTIPLE SAFETY ISSUES WERE IDENTIFIED. GE REPS WERE CONTACTED AND CAME ON SITE TO ASSIST, HOWEVER, THE ISSUES PERSISTED. THE MONITOR WAS REMOVED FROM SERVICE AND REPLACED WITH ANOTHER MFR'S PRODUCT. MATERNAL HR DOES NOT AUTOMATICALLY TRACE ON PAPER. REQUIRES REPEATED MANUAL ADJUSTMENTS. DELAY IN ESTABLISHING FHR INITIALLY AND WHEN PT IS PUSHING. DIFFICULTY MONITORING UTERINE CONTRACTIONS. BP NOT WORKING. FSE: FHR SUDDENLY STOPPED WORKING, TOOK 15 MINS TO REESTABLISH. NURSES HAVING TO USE "TRICKS" TO GET ACCURATE FHR TRACINGS. BACKGROUND NOISE ON THE US IS TOO LOUD. FHR TOO SOFT AND DIFFICULT TO HEAR. PRINTER PAPER WON'T ADVANCE. IF PAPER RUNS OUT, UNABLE TO REPRINT TRACING ON NEW PAPER. TOCO DOES NOT RETURN TO BASELINE WHEN PT RETURNS AND REPLUGS AFTER GOING TO THE RESTROOM. US MONITOR WAS BEING HELD IN THE AIR AND NOT ON PT AND WAS READING FHTS OF 140'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214803 ELECTRONIC FETAL MONITOR COROMETRICS ELECTRONIC FETAL MONITOR SYSTEM, MONITORING, PERINATAL HGM GE HEALTHCARE 259CX-D COROMETRICS

    Patients

    Seq Age Sex Outcome Treatment
    1