BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM50

    MDR report key: 4021145 · Received August 15, 2014

    Report

    Report Number
    MW5037732
    Event Type
    Death
    Date Received
    August 15, 2014
    Date of Event
    May 3, 2014
    Report Date
    August 4, 2014
    Manufacturer
    PHILLIPS
    Product Code
    KNG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, AT 13:35, A 40 WEEKS AND 5 DAYS PREGNANT FEMALE PRESENTED TO HOSPITAL FOR INDUCTION OF LABOR SECONDARY TO POST TERM PREGNANCY AND NEWLY DIAGNOSED GESTATIONAL HYPERTENSION. FETAL MONITOR WAS CONNECTED. ON (B)(6) 2014, AT 21:27, A FEMALE INFANT WAS BORN WITH TIGHT DOUBLE NUCHAL CORD NOTED AND HANDED IMMEDIATELY TO PEDIATRICIAN. CHEST COMPRESSIONS AND RESPIRATORY ASSISTANCE WERE STARTED AND CODE PINK CALLED AT LESS THAN ONE MINUTE OF LIFE WITH APGARS 0/0/0/2. THE INFANT WAS RESUSCITATED AND TRANSPORTED VIA CRITICAL CARE TEAM TO OUTSIDE FACILITY NICU. THE INFANT EXPIRED ON (B)(6) 2014, AT 06:03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490695 AVALON FM50 FETAL MONITOR KNG PHILLIPS FM50

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death