BEUDAMED
    FDA Adverse Event Death Summary report: N

    FETALGARD 3000

    MDR report key: 128911 · Received October 29, 1997

    Report

    Report Number
    1219601-1997-00001
    Event Type
    Death
    Date Received
    October 29, 1997
    Date of Event
    October 2, 1997
    Report Date
    October 3, 1997
    Manufacturer
    ANALOGIC CORPORATION
    Product Code
    KXN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN INFANT WAS STILL-BORN WHILE THE MOTHER WAS BEING MONITORED BY THE DEVICE (FETALGARD 3000 MONITOR), AND ADDITIONALLY BY A WATCHCHILD MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETALGARD 3000 FETAL MONITOR KXN ANALOGIC CORPORATION IP10-E-104 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other