BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERIES 50 XM FETAL/MATERNAL MONITOR

    MDR report key: 343385 · Received July 24, 2001

    Report

    Report Number
    9610816-2001-00161
    Event Type
    Death
    Date Received
    July 24, 2001
    Date of Event
    March 20, 2001
    Report Date
    March 21, 2001
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO AGILENT TECHNOLOGIES THAT A PARENT WAS CONNECTED TO THE FETAL MONITOR AND THERE WAS A NORMAL HEALTHY REACTIVE HEART RATE TRACING ON THE CHARTING SYSTEM. AFTER 20 MINUTES MONITORING STOPPED, AND AFTER 12 HOURS THE FETUS WAS DELIVERED STILL BORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33301 SERIES 50 XM FETAL/MATERNAL MONITOR PERINATAL MONITORING SYSTEM HGM AGILENT TECHNOLOGIES DEUTSCHLAND GMBH M1350B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death