BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOLUSON-I

    MDR report key: 1556600 · Received December 8, 2009

    Report

    Report Number
    8020021-2009-00002
    Event Type
    Death
    Date Received
    December 8, 2009
    Date of Event
    November 27, 2009
    Report Date
    December 8, 2009
    Manufacturer
    GE MEDICAL SYSTEMS KRETZTECHNIK GMBH & CO. OHG
    Product Code
    IYO
    PMA / PMN Number
    K061682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A FETAL DEATH OCCURRED IN 2009 FOLLOWING AN AMNIOCENTESIS PROCEDURE. WHEN THE DOCTOR FIRST INTRODUCED THE SYRINGE, THE NEEDLE WAS VISIBLE AT THE VERY BEGINNING, BUT THEN DISAPPEARED ON THE VOLUSON-I SCREEN. THE DOCTOR USED A THICKER NEEDLE WITH THE SECOND ATTEMPT, BUT THE SAME ISSUE OCCURRED. DURING THE THIRD ATTEMPT, THE NEEDLE AGAIN DISAPPEARED, AND A VEIN WAS DAMAGED. THE CUSTOMER ALLEGES THAT WHEN USING THIS SAME DEVICE TWO DAYS PRIOR TO DEATH, THE DOCTOR NOTICED A DRIFT OF 1 CENTIMETER BETWEEN THE ACTUAL NEEDLE POSITION AND THE THEORETICAL POSITION ON THE SCREEN. A GE FIELD SERVICE ENGINEER (FE) WENT ONSITE TO EXAMINE THE VOLUSON-I DEVICE INVOLVED IN THE EVENTS. THE SAME PROBE WAS USED, HOWEVER, THE NEEDLE SUPPORT, NEEDLE ADAPTER AND NEEDLE INVOLVED IN THE REPORTED EVENTS WERE DISCARDED BY THE HOSPITAL, AND THEREFORE WERE UNAVAILABLE FOR INVESTIGATION. THE TESTS FOR THE THREE ANGLE POSITIONS WERE COMPLETED SUCCESSFULLY. THE FE COLLECTED THE LOG FILES FOR THE ASSOCIATED EVENT AND WILL SEND TO GE HEALTHCARE ENGINEERING FOR FURTHER INVESTIGATION. THE DEVICE IS CURRENTLY IN QUARANTINE IN THE HOSPITAL'S BIOMEDICAL DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUSON-I ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO GE MEDICAL SYSTEMS KRETZTECHNIK GMBH & CO. OHG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death