BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINS CAPABLE FETAL MONITOR

    MDR report key: 31564 · Received March 20, 1996

    Report

    Report Number
    31564
    Event Type
    Malfunction
    Date Received
    March 20, 1996
    Date of Event
    January 22, 1996
    Report Date
    March 6, 1996
    Manufacturer
    HEWLETT PACKARD CO.
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    QUOTED FROM NURSE'S REPORT "I HAVE BOTH EFM (EXTERNAL FETAL MONITOR) AND IFM (INTERNAL FETAL MONITOR) RECORDED FHR (FETAL HEART RATE) 110-120'S FOR #1 TWIN FROM 1511 PM UNTIL PT BROUGHT TO DELIVERY ROOM AT 2238; THERE WAS BOTH AUDIBLE AND VISIBLE TRACING. I BROUGHT FETAL MONITOR TO DELIVERY ROOM AND CONTINUED TO USE EXTERNAL FETAL MONITOR ON BOTH TWIN 1 AND TWIN 2 DURING FORCEPS DELIVERY. AT DELIVERY OF TWIN 1'S HEAD IT WAS OBVIOUS THAT SHE, AN INFANT GIRL, WAS A FETAL DEATH IN UTERO PROBABLY GREATER THAN 48 HOURS BECAUSE OF THE MACERATED APPEARANCE." TWIN #2 WAS DELIVERED ALIVE WITHOUT INCIDENT. AN AUTOPSY WAS PERFORMED ON TWIN #1. THE AUTOPSY REPORT REVEALED: 1. INTRAUTERINE FETAL DEMISE. 2. MACERATED 36 WEEK FEMALE FETUS (202.5 GRAMS). 3. DICHODONIC; DIAMNIOTIC PLACENTA SHOWING MULTIPLE FOCI OF VILLOUS EDEMA CONSISTENT WITH FETAL HYPOXIA. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINS CAPABLE FETAL MONITOR TWINS CAPABLE FETAL MONITOR KXN HEWLETT PACKARD CO. M1350A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR