BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM30

    MDR report key: 1481560 · Received September 16, 2009

    Report

    Report Number
    MW5012783
    Event Type
    Malfunction
    Date Received
    September 16, 2009
    Date of Event
    September 15, 2009
    Report Date
    September 16, 2009
    Manufacturer
    PHILIPS MEDICAL SYS
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WE ARE USING 4EA PHILIPS FETAL MONITORS -MODEL AVALON FM30'S-. WE HAVE HAD NUMEROUS COMPLAINTS REGARDING NO CALCULATION OF THE FETAL HEART RATE, ALTHOUGH THERE IS A VERY STRONG AUDIBLE DOPPLER SOUND COMING FROM THE MONITOR. WITHOUT ANY USER INTERVENTION, THE FHR -FETAL HEART RATE- WILL SUDDENLY APPEAR. WE ARE USING THE MONITORS FOR NST'S -NON STRESS TESTING- IN OUR HIGH RISK PREGNANCY PRE-NATAL CARE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FM30 FETAL MONITOR KXN PHILIPS MEDICAL SYS AVALON FM30 DE53107006

    Patients

    Seq Age Sex Outcome Treatment
    1