BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROMETRICS

    MDR report key: 7373194 · Received March 26, 2018

    Report

    Report Number
    MW5076151
    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 REPRESENTATIVES WERE CONTACTED AND CAME ON SITE TO ASSIST; HOWEVER, THE ISSUES PERSISTED. THE MONITOR WAS REMOVED FROM SERVICE AND REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. MATERNAL HR DOES NOT AUTOMATICALLY TRACE ON PAPER: REQUIRES REPEATED MANUAL ADJUSTMENTS, DELAY IN ESTABLISHING FHR INITIALLY AND WHEN PATIENT IS PUSHING, DIFFICULTY MONITORING UTERINE CONTRACTIONS, BP NOT WORKING, FSE: FHR SUDDENLY STOPPED WORKING, TOOK 15 MINUTES 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 PATIENT RETURNS AND REPLUGS AFTER GOING TO THE RESTROOM AND US MONITOR WAS BEING HELD IN THE AIR AND NOT ON PATIENT AND WAS READING FHT'S OF 140'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214806 COROMETRICS ELECTRONIC FETAL MONITOR HGM GE HEALTHCARE 259CX-D

    Patients

    Seq Age Sex Outcome Treatment
    1