BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FETAL MONITOR FM50

    MDR report key: 5642870 · Received May 10, 2016

    Report

    Report Number
    5642870
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 29, 2016
    Report Date
    May 4, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FETAL HEART MONITOR ULTRASOUND PROBE BURNED PATIENT. THERE WAS ANOTHER SIMILAR EVENT WITH THE SAME TYPE PROBE THAT OCCURRED RECENTLY AS WELL. MANUFACTURER RESPONSE FOR FETAL HEART RATE ULTRASOUND PROBE, FHR MONITORING PROBE (PER SITE REPORTER): SERVICE REP MAKING ARRANGEMENTS FOR INSPECTION. MANUFACTURER RESPONSE FOR AVALON FM50 FHM, AVALON FM50 (PER SITE REPORTER): SERVICE REP WILL BE MAKING ARRANGEMENTS TO HAVE IT INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299238 AVALON FETAL MONITOR FM50 PERINATAL MONITORING SYSTEM AND ACCESSORIES HGM PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other NO