BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERIES 50 XM FETAL/MATERNAL MONITOR

    MDR report key: 1904069 · Received November 16, 2010

    Report

    Report Number
    9610816-2010-00744
    Event Type
    Death
    Date Received
    November 16, 2010
    Report Date
    November 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K900480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER'S REPORT STATES THAT THEY WERE AWARE THAT THE BABY WAS NOT ALIVE, BUT THEY WERE ABLE TO OBTAIN HR SOUNDS. THIS IS BEING REPORTED ONLY BECAUSE USE OF THE DEVICE WAS COINCIDENT WITH THE STILLBIRTH. THERE IS NO ALLEGATION OR INDICATION THAT USE OF THE DEVICE WAS A FACTOR IN THE STILLBIRTH. THE ABILITY TO OBTAIN MATERNAL HR USING THE US TRANSDUCER IS EXPECTED IF THE USERS MOVE THE TRANSDUCER UNTIL THEY OBTAIN HR SOUNDS. THE DEVICE LABELING IS CLEAR THAT USERS ARE TO VERIFY FETAL LIFE BEFORE MONITORING AND THAT USERS SHOULD USE THE COINCIDENCE DETECTION (CCV) FEATURE TO ASSURE THAT THE MONITORING IS NOT EXCLUSIVELY MATERNAL.

    Description of Event or Problem · 1

    THE USER'S REPORT STATES THAT THEY WERE AWARE THAT THE BABY WAS NOT ALIVE, BUT THEY WERE ABLE TO OBTAIN HR SOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 50 XM FETAL/MATERNAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M1350B

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death