BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 4189814 · Received October 17, 2014

    Report

    Report Number
    3006795936-2014-00029
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN RECEIVED THE BLUE BULLSEYE ON THE VPS CONSOLE STARTING AT 36CM THROUGH 43CM. THE TOTAL LENGTH OF MEASUREMENT WAS 43CM. THIS HAS BEEN AN ONGOING ISSUE FOR OVER A WEEK. THEY HAVE PERFORMED X-RAYS TO CONFIRM CORRECT CATHETER PLACEMENT IN CAJ. THERE HAVE BEEN DELAYS IN TREATMENT WITH NO PT DEATHS OR COMPLICATIONS REPORTED. IT IS NOT KNOWN HOW MANY TIMES THIS HAS OCCURRED. IT WAS NOTED ECG CALIBRATION WAS SUCCESSFUL. THIS IS CASE # (B)(4) ON THE UNIT. THE PROCEDURE WAS BEING PERFORMED ON A MALE PT. THE CATHETER LOOKED NORMAL ON THE CHEST X-RAY TGE CAJ PLACEMENT WAS AT 43CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660426 VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1