BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRONIC FETAL MONITOR 250

    MDR report key: 2042590 · Received March 29, 2011

    Report

    Report Number
    2042590
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GE
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF EPIDURAL IN PROGRESS ON PATIENT IN ACTIVE LABOR. UNABLE TO OBTAIN ADEQUATE QUALITY ELECTRONIC FETAL MONITOR TRACING VIA EXTERNAL MODE. PHANTOM SIGNAL OVERRIDING TRUE EXTERNAL FETAL HEART RATE SIGNAL. MULTIPLE CHANGES OF EXTERNAL ULTRASOUND TRANSDUCER WERE PERFORMED WITH NO IMPROVEMENT OF SIGNAL. APPLIED INTERNAL FSE. THREE DAYS AFTER THE EVENT, A CLINICAL ENGINEERING TECHNICIAN PREFORMED THE FOLLOWING TESTS ON THE MONITOR (IN THE ROOM WHERE THE EVENT OCCURRED), MECG, FECG, ULTRASOUND, FETAL MOVEMENT DETECTION AND UTERINE ACTIVITY, AS LISTED IN THE SERVICE MANUAL PAGES; PAGE 4-24 TO PAGE 4-36. ALL TESTS PASSED AND A COPY OF THE STRIP CHART RECORDING WAS LEFT ON THE FETAL MONITOR. HOWEVER, THERE WAS A NOTICEABLE INTERFERENCE NOISE OCCURRING EVERY 8 SECONDS AND LASTING ABOUT 1/2 A SECOND. THREE FETAL MONITORS WERE TESTED WITH THE SAME CONSISTENT PROBLEM OBSERVED. THE ELECTRICITY OUTLETS WERE CHECKED WITH A POLARITY TESTER, AND THEY WERE FOUND TO BE OK. THE NEXT DAY, UNIT STAFF INDICATED THAT NO INTERFERENCE WAS OBSERVED, HOWEVER THE PROBLEM HAS OCCURRED IN OTHER PATIENT ROOMS. AS THIS SEEMS TO BE AN INTERMITTENT ISSUE, CLINICAL ENGINEERING WILL BE PAGED WHEN THE PROBLEM IS OBSERVED AGAIN SO A LIVE ASSESSMENT CAN BE MADE. THE MANUFACTURER HAS BEEN INFORMED OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRONIC FETAL MONITOR 250 ELECTRONIC FETAL MONITOR HGM GE 250 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *