BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VASCULAR POSITIONING SYSTEM

    MDR report key: 3966156 · Received June 25, 2014

    Report

    Report Number
    3006795936-2014-00019
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 24, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO A FEMALE PT. THE INSERTION WAS A ROUTINE PROCEDURE AND WAS ABOUT 3/4 OF THE WAY COMPLETE. THE NURSE SMELLED AND SAW SMOKE COMING OUT OF THE BACK OF THE VPS CONSOLE WHERE THE SCREEN MEETS THE KEYBOARD. THE CONSOLE WAS THEN TURNED OFF. THE NURSE FINISHED THE PROCEDURE WITHOUT THE CONSOLE AND A CHEST X-RAY WAS USED TO VERIFY CATHETER PLACEMENT. THERE WAS A DELAY IN TREATMENT WITH NO PT HARM AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369617 VASONOVA VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1