BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VASCULAR POSITIONING SYSTEM

    MDR report key: 3837945 · Received March 6, 2014

    Report

    Report Number
    3006795936-2014-00003
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN WAS USING THE VPS CONSOLE FOR CATHETER PLACEMENT ON A PATIENT. SHE HAD ALMOST COMPLETED THE INSERTION WHEN SHE NOTICED THE CONSOLE POWER SUPPLY WAS SMOKING. SHE WAS ABLE TO COMPLETE THE CATHETER INSERTION SUCCESSFULLY FOR THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134499 VASONOVA VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1