BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID

    MDR report key: 2984985 · Received February 26, 2013

    Report

    Report Number
    1000589001-2013-00001
    Event Type
    Death
    Date Received
    February 26, 2013
    Report Date
    February 8, 2013
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ARJOHUNTLEIGH, INC. (B)(4) IS SUBMITTING THE REPORT ON BEHALF HUNTLEIGH (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    TELEPHONE CONFERENCE WITH DR. (B)(6) 2013: 2X TRACES PERFORMED ON A PATIENT AT 29 WKS G.A. DAWES REDMAN CRITERIA MET ON BOTH TRACES. HOWEVER, TRACE WAS REPORTED AS HAVING AN UNSTABLE BASELINE, REDUCED VARIABILITY AND REPEATED DECELERATIONS. SCAN APPROXIMATELY 2 OR 3 HOURS LATER REVEALED A DEAD FETUS. PATIENT HAD MILD TO MODERATE PRE-ECLAMPSIA AND PLACENTAL ABRUPTION, POSSIBLY OCCURRING AT SOME POINT DURING THE CTG TRACES. ON DELIVERY, A SIZEABLE CLOT OBSERVED IN THE PLACENTA CONFIRMING AN ABRUPTION. HOWEVER, NO SIGNIFICANT HAEMORRHAGING OR PAIN AT THE TIME, SO SOMEWHAT UNUSUAL CASE. LATER MATERNAL PAIN LATER TRIGGERED SCAN. MOTHER OK. ON THE PRINT-OUT, CARE S/W VERSION REPORTED AS "CARE V.1.6.1 NO. 1/30150".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81715 SONICAID FM800 RANGE OF FETAL MONITORS HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS FM830ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death