BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID

    MDR report key: 2659561 · Received July 17, 2012

    Report

    Report Number
    1000589001-2012-00002
    Event Type
    Death
    Date Received
    July 17, 2012
    Report Date
    May 9, 2012
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(4) ON BEHALF OF THE MANUFACTURER HUNTLEIGH HEALTHCARE (B)(4). (B)(4). A COMPLAINT WAS RECEIVED VIA OUR (B)(4) DISTRIBUTOR RELATING TO AN INCIDENT AT A (B)(6) HOSPITAL, IN WHICH A FETUS HAD DIED. ONE OF OUR TEAM FETAL MONITORS WAS USED TO MONITOR THIS FETUS ON A NUMBER OF OCCASIONS IN THE PERIOD IMMEDIATELY PRECEDING THE FETAL DEATH - THE EXACT TIMESCALE BETWEEN THE LAST MONITORING SESSION AND THE TIME AT WHICH THE FETUS WAS DETERMINED TO BE DEAD IS NOT KNOWN. CONCLUSION: FROM THE INVESTIGATION, THE FOLLOWING CONCLUSIONS ARE DRAWN: THIS FETUS DEATH IS IN NO WAY ASSOCIATED WITH ANY MALFUNCTION OR FAULT IN OUR PRODUCT.

    Description of Event or Problem · 1

    FETUS DIED, DESPITE STV BEING >4 ON 6 TRACES DONE OVER THE 2 DAYS BEFORE THE BABY'S DEATH. IN THE MANUAL THERE IS A TABLE SHOWING THAT THE PROBABILITY OF FETAL DEATH, WHEN STV >4 IS ZERO. HOWEVER, THE ANALYSIS HAD ALSO FAILED TO MEET THE CRITERIA ON 5 TRACES (NOT CLEAR IF THESE WERE 5 OUT OF THE 6, OR 5 DIFFERENT TRACES), WITH SIGNIFICANT RISK INDICATORS, INCLUDING SINUSOIDAL PATTERN. THESE RISK INDICATORS WOULD APPEAR TO HAVE BEEN IGNORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICAID NONE HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS TEAMCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death