BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRSHIELDS FETALGARD 3000

    MDR report key: 139827 · Received December 24, 1997

    Report

    Report Number
    139827
    Event Type
    Death
    Date Received
    December 24, 1997
    Date of Event
    October 2, 1997
    Report Date
    December 22, 1997
    Manufacturer
    ANALOGIC CORP/ LIFECARE GROUP
    Product Code
    KXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 37-YR-OLD PRESENTED TO L+D FOR DELIVERY. ORIGINALLY USING EXTERNAL MONITOR. AFTER EPIDURAL PLACED ATTEMPTED TO USE INTERNAL MONITOR. COULD NOT OBTAIN A GOOD TRACING AND HAD TO GO BACK TO USING EXTERNAL MONITOR. STILLBIRTH RESULTED. BIOMEDICAL EXAMINED EQUIPMENT & FOUND: UPON CONNECTION OF ECG STIMULATOR TO THE FECG SCALP ELECTRODE ADAPTER, WHENEVER THE FECG IS STRESSED, THE SIGNAL IS LOST OR ARTIFACT PRODUCED. CRACK IN PRONGS OF SCALP ELECTRODE ADAPTER. EQUIPMENT HIGHLY SENSITIVE, PICKS UP & PRODUCES TRACINGS EVEN WHEN NOT CONNECTED TO FETAL SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS FETALGARD 3000 FETAL MONITOR KXN ANALOGIC CORP/ LIFECARE GROUP IP10-E-104 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death