BEUDAMED
    FDA Adverse Event Death Summary report: N

    FETAL MONITOR

    MDR report key: 689596 · Received March 20, 2006

    Report

    Report Number
    9610816-2006-00066
    Event Type
    Death
    Date Received
    March 20, 2006
    Date of Event
    November 19, 2005
    Report Date
    February 21, 2006
    Manufacturer
    PHILIPS MEDIZINSYSTEME BOBLINGEN
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER MISTAKENLY TRACED THE MATERNAL HEART RATE (MHR) RATHER THAN THE FETAL HEART RATE (FHR). THE USER DID NOT CONFIRM THE FHR BEFORE APPLYING THE TOCO AND TRACED THE MHR. THE FETUS WAS STILLBORN UPON DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR FETAL MONITOR HGM PHILIPS MEDIZINSYSTEME BOBLINGEN M1353A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death