BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID

    MDR report key: 3935231 · Received June 27, 2014

    Report

    Report Number
    1419652-2014-00168
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 19, 2014
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD, DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) GESTATION FETUS WHO WAS DELIVERED STILLBORN (AT THE END OF THE TRACE AT 21:27). THE BABY WAS VERY OEDEMATOUS AND SWOLLEN AND DIFFICULT TO DELIVER: THERE WERE ANTENATAL COMPLICATIONS WHICH WERE NOT PREVIOUSLY KNOWN. THE PRELIMINARY POST MORTEM REPORT SUGGESTS THAT THE FETUS HAD DIED AT LEAST 12 HOURS PRIOR TO DELIVERY I.E. BEFORE THE MONITORING STARTED. THE TRACE SEEMS TO REFLECT THE PRESENCE OF A FETAL HEART RATE BUT IT DOES NOT APPEAR TO BE THE SAME AS THE MATERNAL HEART RATE. REFERENCE MFR REPORT NUMBER: 1000589001-2014-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377999 SONICAID HGM HUNTLEIGH HEALTHCARE LTD, DIAGNOSTICS FM830ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death