BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VASCULAR POSITIONING SYSTEM

    MDR report key: 3964674 · Received May 30, 2014

    Report

    Report Number
    3006795936-2014-00012
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING CATHETER INSERTIONS BY THE PICC TEAM IN PT'S UPPER EXTREMITIES THEY HAVE EXPERIENCED DIFFICULTY WITH THE VPS. WITH RETROGRADE FLOW THEY ARE GETTING A GREEN ARROW. THIS WAS WITNESSED BY THE CLINICAL SUPPORT SPECIALIST AND WAS SEEN ON THE CASES STORED IN THE CONSOLE. THERE HAVE BEEN NO DELAYS IN TREATMENT AND NO PT DEATHS OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320000 VASONOVA VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1