BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOLUSON E8

    MDR report key: 2140423 · Received June 21, 2011

    Report

    Report Number
    8020021-2011-00003
    Event Type
    Death
    Date Received
    June 21, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    IYO
    PMA / PMN Number
    K061682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INTRAUTERINE DEATH IS UNDETERMINED, BUT WAS DETECTED (B)(4) 2011. THE DEVICE WAS EVALUATED BY GE HEALTHCARE ENGINEERING AND THE SYS WAS DETERMINED TO BE OPERATING PER SPECIFICATIONS. THE PT'S DATA FILE FROM (B)(4) 2011 WAS AVAILABLE AND ANALYZED. THE MEASUREMENT FUNCTIONALITY OF THE ULTRASOUND SYS WAS ANALYZED AND THE RESULTS WERE VERIFIED AGAINST THE SCALE ON THE SIDE OF THE SCREEN. NO ABNORMALITY WAS DETECTED. THE DEVICE'S CALCULATIONS AND PERCENTILES WERE VERIFIED WITH PUBLISHED GROWTH CHARTS. NO ABNORMALITY WAS DETECTED. THE ESTIMATED FETAL WEIGHT CALCULATION WAS VERIFIED WITH THE PUBLISHED CHART AND AGAIN NO ABNORMALITY WAS DETECTED. BASED ON THE EVAL OF THE SYS AND THE RE-ANALYSIS OF THE (B)(4) 2011 DATA, THE SYS PERFORMED PER SPECIFICATIONS. THE CAUSE OF THE INTRAUTERINE DEATH IS UNDETERMINED OR HAS NOT BEEN MADE AVAILABLE TO GE HEALTHCARE. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    AN OBSTETRIC PT PRESENTED ON (B)(6) 2011, AT A GESTATIONAL AGE OF 38+6 WEEKS. DURING ROUTINE MEASUREMENTS, THE SONOGRAPHER CALCULATED AN ESTIMATED FETAL WEIGHT (EFW) OF 7 LB 13 OZ, THE BIPARIETAL DIAMETER (BPD) SHOWING UP AT THE 18%, THE HEAD CIRCUMFERENCE (HC) BELOW 2.3%, ABDOMINAL CIRCUMFERENCE (AC) AT 95%, AND FEMUR LENGTH (FL) AT 12%. THE PT RETURNED ON (B)(6) 2011 AND AN INTRAUTERINE DEATH WAS DETECTED. THE FETUS WAS DELIVERED AND THE WEIGHT WAS APPROX 10 LB. THE HEAD CIRCUMFERENCE ALSO APPEARED LARGE AFTER DELIVERY ALTHOUGH AN ACTUAL MEASUREMENT WAS NOT AVAILABLE. THE DOCTOR INDICATED THAT IF HE HAD KNOWN ABOUT THE TRUE WEIGHT OF THE FETUS, HE WOULD HAVE TAKEN THE MOTHER'S BLOOD GLUCOSE TO MONITOR HER TREATMENT FOR DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUSON E8 ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death