BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYS

    MDR report key: 4148042 · Received October 2, 2014

    Report

    Report Number
    3006795936-2014-00027
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED WITH THE USE OF THE VPS. DURING INSERTION, THE CLINICIAN RECEIVED AN ORANGE SYMBOL WHEN ADVANCING THE CATHETER ALL THE WAY INTO THE PT AND THEN A BLUE BULLSEYE APPEARED. AN X-RAY WAS PERFORMED AND CONFIRMED THE CATHETER WAS IN A GOOD POSITION. THERE WAS A DELAY IN TREATMENT WITH NO PT HARM AND NO PT DEATH OR COMPLICATIONS REPORTED. PER THE CLINICAL SUPPORT SPECIALIST, NO ADDITIONAL DETAILS OF THE EVENT ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615453 VASCULAR POSITIONING SYS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1