BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL GUARD

    MDR report key: 199239 · Received November 16, 1998

    Report

    Report Number
    199239
    Event Type
    Injury
    Date Received
    November 16, 1998
    Date of Event
    November 3, 1998
    Report Date
    November 16, 1998
    Manufacturer
    AIR SHIELDS - VICKERS
    Product Code
    HEL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED IN LABOR AND WAS ASSESSED IN TRIAGE USING FETAL MONITOR. FETAL MONITOR STRIP SHOWED FETAL HEART TONES 150-160. PT ADMITTED AND MOVED TO ANOTHER ROOM WITH ANOTHER FETAL MONITOR. THIS MONITOR ALSO SHOWED FETAL HEART TONES AT 150-160 WITH OCCASIONAL BREAKS WHERE RATE DROPPED TO 70-80'S WHICH WAS ASSESSED AS MATERNAL HEART RATE. RATE ALWAYS RETURNED TO 150'S. PHYSICIAN CAME IN TO DELIVER BABY. HE RUPTURED BAG OF WATER AND APPLIED FETAL SCALP ELECTRODE - NO HEART RATE WAS ATTAINABLE BY MONITOR OR DOPTONE. AN EMERGENCY C-SECTION WAS DONE WITH DELIVERY OF STILLBORN MALE. AUTOPSY REPORTED BABY HAD BEEN DEAD IN UTERO FOR UP TO 48 HOURS PRIOR TO DELIVERY. FETAL MONITORS APPARENTLY WERE DOUBLING MATERNAL RATE FOR FETAL HEART TONE. MONITORS UNDER WARRANTY AND REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL GUARD FETAL MONITOR HEL AIR SHIELDS - VICKERS FTLGRD 3000 *
    2 FETALGUARD FETAL MONITOR HEL AIR SHIELDS - VICKERS FTLGRD 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization IV THERAPY PUMP