BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 5042825 · Received August 31, 2015

    Report

    Report Number
    2021710-2015-01531
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 4, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS (FA) LAB RECEIVED VELA MAIN PCBA. FA INSTALLED THE MAIN PCBA IN TO A KNOWN GOOD VELA UNIT. UPON START UP, UNIT RECEIVED ¿VENT INOP¿. THE EVENT LOG INDICATED POST DAC OR ADC ERROR (8, 4013, 2). VOLTAGE AT R608 MEASURED 0.001 VDC COMPARED TO A FUNCTIONAL MAIN PCBA OF BETWEEN 3.8 AND 4.189 VDC.

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION IS STILL AWAITING THE RETURN OF THE ALLEGED FAULTY UNIT. AS OF AUGUST 31, 2015, THE UNIT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THIS COMPLAINT ORIGINATED FROM A FOREIGN DISTRIBUTOR IN (B)(4). THE DISTRIBUTOR REPORTED A UNIT THAT WAS ALARMING VENT INOP. THE EVENT OCCURRED DURING TESTING, NO PATIENT INVOLVEMENT. THE CUSTOMER REQUESTED TO SEND THE UNIT IN FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576766 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA

    Patients

    Seq Age Sex Outcome Treatment
    1