BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETAL MONITOR

    MDR report key: 929952 · Received October 16, 2007

    Report

    Report Number
    929952
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    September 28, 2007
    Report Date
    October 16, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SOUNDED LIKE MATERNAL HEART RATE (MHR), AND FETAL HEART RATE (FHR) DISPLAY READS 80-90. THE PRINTING ON THE PAPER STRIP READING 170'S. NOT SURE IF IT WAS RECORDING MHR OR DOUBLE COUNTING. TRACING NOT INTERPRETABLE; VARYING FROM 95-200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR MONITOR, FETAL HGM PHILIPS MEDICAL SYSTEMS AVALON FM30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR