BEUDAMED
    FDA Adverse Event Death Summary report: N

    KENDALL/TYCO HEALTHCARE

    MDR report key: 876852 · Received June 20, 2007

    Report

    Report Number
    876852
    Event Type
    Death
    Date Received
    June 20, 2007
    Date of Event
    April 9, 2007
    Report Date
    May 17, 2007
    Manufacturer
    KENDALL/TYCO HEALTHCARE
    Product Code
    HGP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CABLE USED TO MONITOR BABY INTRAUTERINE QUIT TRACING PT/BABY ON FETAL HEART MONITOR. BABY STILLBORN. MONITOR TESTED OKAY, BUT CABLE TEST WOULD NOT PICK UP ANY TRACINGS. CHANGED KENDALL CABLE AND WAS ABLE TO PICK UP PT'S HEART RATE/TRACING BEFORE ITS DEATH INTRAUTERINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL/TYCO HEALTHCARE KENDALL LIFE TRACE SAFELINE FSC SYSTEM CABLE HGP KENDALL/TYCO HEALTHCARE 00275 FCB400 FSE CBL CORO 430789

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death