BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 4460543 · Received January 26, 2015

    Report

    Report Number
    3006795936-2015-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2015
    Date of Event
    January 2, 2015
    Report Date
    January 2, 2015
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO: THE CONSOLE WAS SWAPPED OUT FOR THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING CATHETER PLACEMENT WITH THE VPS, THAT THE CATHETER WAS CONFIRMED TO BE IN THE PATIENT'S CAJ BUT THERE WAS NO BLUE BULLSEYE PRESENT ON THE CONSOLE. WHEN IN THE CAJ, THE ORANGE SYMBOL WAS SOLID AND DID NOT CHANGE. AN X-RAY WAS PERFORMED AND CONFIRMED THE CATHETER LOCATION. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THAT THE ECG DID NOT CALIBRATE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60254 VASCULAR POSITIONING SYSTEM OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1