BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID FETAL MONITOR ANTEPARTUM

    MDR report key: 24649187 · Received March 20, 2026

    Report

    Report Number
    1419652-2026-00083
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    September 16, 2025
    Report Date
    February 11, 2026
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE CARDIOTOCOGRAPH WAS USED ON AN ANTENATAL PATIENT WITH REDUCED FETAL MOVEMENTS AT 39+1 WEEKS. THE DAWES-REDMAN CRITERIA WERE MET AFTER 20 MINUTES AND THE CARDIOTOCOGRAPH WAS DISCONTINUED. THE MOTHER HAD AN EMERGENCY CAESAREAN BIRTH THE FOLLOWING DAY. BABY WAS IN POOR CONDITION, SEVERELY ANAEMIC AT BIRTH AND DIED AROUND 6 HOURS LATER. FETO-MATERNAL HAEMORRHAGE WAS CONFIRMED ON KLEIHAUER. ON VISUAL RETROSPECTIVE REVIEW OF THE CARDIOTOCOGRAPH THAT MET DAWES-REDMAN CRITERIA THE DAY BEFORE BIRTH, A SINUSOIDAL PATTERN WAS IDENTIFIED. THE DAWES-REDMAN ANALYSIS HAD NOT DETECTED THE SINUSOIDAL PATTERN. SW VERSION 19.4.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715222 SONICAID FETAL MONITOR ANTEPARTUM SYSTEM, MONITORING, PERINATAL HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS ST3A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death