BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4707834 · Received April 14, 2015

    Report

    Report Number
    2021710-2015-00755
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CALLED BACK AND REPORTED THAT THEY PERFORMED OVP PREVENTATIVE MAINTENANCE, AS PER THE SERVICE MANUAL AND THE UNIT IS NOW WORKING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF THEIR UNITS PASSED USER VERIFICATION TESTS (UVT) HOWEVER, THE VOLUMES ARE LOW. CAREFUSION TECHNICAL SUPPORT ADVISED THE CUSTOMER TO TRY THE TURBINE DIFFERENTIAL CALIBRATION, AND IF THAT DOES NOT HELP THEN THE UNIT WILL PROBABLY NEED A NEW TURBINE. THE REPORTED EVENT OCCURRED DURING OPERATION VERIFICATION PROCEDURE (OVP) TESTING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249516 CAREFUSION CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1