BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 4298026 · Received November 26, 2014

    Report

    Report Number
    3006795936-2014-00030
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 13, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    B)(4). THE CONSOLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PT'S RIGHT ARM. THE CLINICIAN HAD AN EXTERNAL APPEARED ON THE VPS AND WHEN ADVANCING THE CATHETER FURTHER, THE ORANGE SYMBOL APPEARED. CATHETER WAS LEFT AT 31CM AND A CHEST X-RAY INDICATED, IT WAS 5CM SHORT OF THE DISTAL SVC-CAJ. THE CATHETER WAS ADVANCED PER THE RADIOLOGIST REQUEST 5CM. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THE ECG CALIBRATION WAS SUCCESSFUL AND A PRELOADED 5FR, 50CM, DUAL LUMEN ARROW KIT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769354 VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1