BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 8331468 · Received February 12, 2019

    Report

    Report Number
    9610816-2019-00044
    Event Type
    Death
    Date Received
    February 12, 2019
    Date of Event
    February 3, 2019
    Report Date
    February 5, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    UDI-DI
    00884838000414
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEATH OF A NEWBORN WAS ASCERTAINED AFTER EMERGENCY C-SECTION AND 19 MINUTES OF RESUSCITATION AT THE HOSPITAL SITE. THE EMERGENCY C-SECTION WAS PERFORMED AFTER A SLOW FETAL HEART RATE WAS IDENTIFIED. THE CUSTOMER PROVIDED A SCAN OF THE TRACE. THE SCAN WAS EVALUATED BY PRODUCT SUPPORT ENGINEERING (PSE) AND RESEARCH AND DEVELOPMENT (R&D). THE PHILIPS AVALON FETAL MONITOR PRINTS A TRACE HEADER WITH THE INFORMATION FOR ALL INVOLVED DEVICES AT THE BEGINNING OF EACH MONITORING EPISODE. THE TRACE HEADER SHOWS THAT THERE WAS ONE FETAL MONITOR AND TWO DIFFERENT TRANSDUCERS USED. THE TWO TRANSDUCERS WERE AN ULTRASOUND TRANSDUCER FOR FETAL HEART RATE (FHR) MEASUREMENT AND A TOCO TRANSDUCER FOR MEASUREMENT OF CONTRACTIONS. THE MATERNAL HEART RATE WAS NOT MEASURED.THE SOFTWARE AND FIRMWARE REVISION OF THE AVALON FM30 FETAL MONITOR WERE CHECKED AND CONFIRMED TO BE VALID. THIS MEANS THAT ALL INVOLVED AVALON DEVICES AND ACCESSORIES WERE UP-TO-DATE FROM A SOFTWARE AND FIRMWARE PERSPECTIVE. IT IS SPECIALLY IMPORTANT THAT THE LATEST SOFTWARE REVISION IS INSTALLED TO THE TRANSDUCER, SINCE THE SIGNAL PROCESSING IS CARRIED OUT IN THE TRANSDUCERS AND NOT IN THE MONITOR. THE DEVICE WAS TESTED BY A FIELD SERVICE ENGINEER (FSE) WHO CONFIRMED IT WAS WORKING AS INTENDED. THE DEVICE REMAINS AT THE CUSTOMER SITE. BASED ON THE PROVIDED TRACES AND THE TESTING OF THE DEVICE BY THE FSE, NO SIGNS OF A FETAL MONITOR MALFUNCTION WERE IDENTIFIED. THE TRACE RECORDING IS OF GOOD QUALITY. THE EXACT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. THE REPORTED ARTIFACTS BETWEEN FETAL HEART RATE AND MATERNAL HEART RATE COULD NOT BE IDENTIFIED. THE MATERNAL HEART RATE WAS NOT MEASURED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. SERIAL NUMBER NOT PROVIDED AT TIME OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEATH OF A NEWBORN AFTER AN EMERGENCY C-SECTION AND 19 MINUTES OF ATTEMPTED RESUSCITATION. ACCORDING TO THE CUSTOMER (BIOMEDICAL ENGINEER) AND CAREGIVERS, ARTIFACTS BETWEEN THE MOTHER¿S PULSE AND THE FETUS' PULSE RATE WERE IDENTIFIED. BUT THEY THINK THE DEVICE WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125957 AVALON FM30 FETAL MONITOR FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2703A 00884838000414

    Patients

    Seq Age Sex Outcome Treatment
    1 Death