BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN ULTRASOUND SYSTEM W/OBSTETRIC CALCULATIONS

    MDR report key: 101169 · Received June 27, 1997

    Report

    Report Number
    2936884-1997-00003
    Event Type
    Malfunction
    Date Received
    June 27, 1997
    Date of Event
    May 5, 1997
    Report Date
    June 10, 1997
    Manufacturer
    ACUSON CORP.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER CALCULATING THE ESTIMATED FETAL WEIGHT (EFW) FOR A PATIENT USING THE ASPEN ULTRASOUND SYSTEM, THE CLINICIAN THOUGHT THE VALUE TO BE UNUSUAL. THIS PROMPTED A STUDY TO COMPARE THE VALUE TO THAT OBTAINED ON AN ACUSON 128XP SYSTEM. FIELD APPLICATIONS SPECIALIST REPORTED THAT THE ASPEN EFW WAS 35 GRAMS LESS THAN THAT FOR THE 128XP. SUBSEQUENT ENGINEERING TESTS ON A FACTORY SYSTEM CONFIRMED THAT AN ERROR IN ONE OF THE AVAILABLE ASPEN SOFTWARE ALGORITHMS FOR CALCULATING EFW WAS PRESENT. THE MAGNITUDE OF THE ERROR WAS DEPENDENT ON THE MAGNITUDE OF THE HEAD CIRCUMFERENCE, BIPARIETAL DIAMETER, FEMUR LENGTH, AND ABDOMINAL CIRCUMFERENCE USED IN THE CALCULATION. AS MUCH AS A 70% ERROR WAS CONFIRMED IN THESE TESTS. BASED ON CLINICAL OPINIONS RECEIVED, MFR BELIEVES THAT THE RISK OF INJURY IS LOW BUT HAS CHOSEN TO FILE THIS REPORT IN THE SPIRIT OF THE REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN ULTRASOUND SYSTEM W/OBSTETRIC CALCULATIONS DIAGNOSTIC ULTRASOUND SYSTEM W/SOFTWARE CALCULATION IYO ACUSON CORP. ASPEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other