BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 999169 · Received November 27, 2007

    Report

    Report Number
    999169
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    October 6, 2007
    Report Date
    November 24, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN LABOR WITH FETAL SCALP ELECTRODE. SIGNIFICANT AMOUNT OF ARTIFACT PRESENT ON TRACING. STAFF TURNED THE "DECG LOGIC" ON (IDENTIFIED IN THE MONITOR AS ARTIFACT SUPPRESSION ON), WHICH DID NOT RESOLVE THE ISSUE. EACH CONTRACTION, ESPECIALLY DURING PUSHING STAGE, HAD A SIGNAL LOSS THAT PREVENTED STAFF FROM SEEING THE DECELERATIONS WITH CONTRACTIONS. ALSO CONTRIBUTING TO THE PROBLEM WITH TRACING INTERPRETATION WAS THE PAPER DRAWER JAMMING AND STAFF BEING UNABLE TO RESOLVE THIS PROBLEM. CONSEQUENTLY, THEY DID NOT HAVE A CONTINUOUS PAPER TRACING TO REVIEW. PHILIPS HAS SAID THAT THE PAPER TRAY DOES JAM IF NOT CLOSED PROPERLY (THEY SPECIFY THE DRAWER MUST BE CLOSED USING A 2-THUMB METHOD). HOWEVER, IT IS UNLIKELY THAT THIS WOULD HAVE RESOLVED THE PROBLEM GIVEN THE NUMBER OF TIMES THE PAPER DRAWER WAS MANIPULATED TO RESOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MONITOR, FETAL HGM PHILIPS MEDICAL SYSTEMS, INC. FM30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR