BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6338035 · Received February 16, 2017

    Report

    Report Number
    2021710-2017-05430
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    December 1, 2016
    Report Date
    February 16, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT FOR INVESTIGATION. THE PT 800, 801 AND 802 HAS RECORDED FAULTS AND FAILED CALIBRATION. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE.

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). THE CUSTOMER REPORTED THE SUSPECTED MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) IS AVAILABLE FOR ANALYSIS AND A RETURN GOOD AUTHORIZATION HAS BEEN ISSUED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECTED MAIN PCBA FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE VELA VENTILATOR; THE UNIT DISPLAYS A TRANSDUCER FAULT ALARM. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER REPORTED THE TURBINE DIFFERENTIAL TRANSDUCER FAILED CALIBRATION TESTING. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117914 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1