BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VASCULAR POSITIONING SYSTEM

    MDR report key: 3994754 · Received June 13, 2014

    Report

    Report Number
    3006795936-2014-00017
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 10, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE ICU/BURN UNIT. THE CLINICIANS EXPERIENCED A HIGH CATHETER PLACEMENT WITH A SEASONED VPS USER. THERE WAS A PROXIMAL TO MID CATHETER PLACEMENT WITH A SUSTAINED BLUE BULLSEYE. CHEST X-RAY WAS TAKEN AND CONFIRMED HIGH PLACEMENT. AS A RESULT, THE CATHETER WAS ADVANCED FURTHER INTO THE PATIENT. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THE PATIENT HAD NORMAL SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350741 VASONOVA VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1