BEUDAMED
    FDA Adverse Event Other Summary report: N

    AU2 SYSTEM

    MDR report key: 111461 · Received August 6, 1997

    Report

    Report Number
    1826555-1997-90001
    Event Type
    Other
    Date Received
    August 6, 1997
    Date of Event
    July 7, 1997
    Report Date
    July 15, 1997
    Manufacturer
    BIOSOUND ESAOTE, INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/2/97 THE TECHNOLOGIST (END USER OF THE DEVICE) WAS SETTING UP THE AU2 SYSTEM PRIOR TO BEGINNING A PT STUDY. IN ITS MOBILE CONFIGURATION THE SYSTEM IS TYPICALLY TRANSPORTED WITH THE RGB MONITOR REMOVED. AS THE MONITOR WAS BEING PLACED BACK INTO POSITION THE FERNO MODEL 288 CART ON WHICH THE SYSTEM WAS INSTALLED TIPPED BACK CAUSING THE AU2 SYSTEM TO FALL ONTO THE TECHNOLOGIST. THE TECHNOLOGIST WAS STRUCK JUST ABOVE THE LEFT KNEE RESULTING IN INJURY TO THE LEFT LEG. ON 7/16/97 AN ON-SITE EVALUATION WAS PERFORMED BY A BIOSOUND ESAOTE FIELD SERVICE ENGINEER. THE ENGINEER DETERMINED THE MOBILE CART HAD BEEN INCORRECTLY ASSEMBLED AT THE TIME OF INSTALLATION. THIS RESULTED IN THE WEIGHT OF THE AU2 BEING UNEVENLY DISTRIBUTED TO THE REAR OF THE CART GIVING IT A TENDENCY TO TIP BACKWARD. THE ENGINEER CORRECTED THE ASSEMBLY ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2 SYSTEM ULTRASOUND IMAGER ITX BIOSOUND ESAOTE, INC. 7050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other