BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6047815 · Received October 21, 2016

    Report

    Report Number
    2021710-2016-04679
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    February 21, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT MAIN PRINTED CIRCUIT BOARD ASSEMBLY FOR INVESTIGATION. AN INVESTIGATION WAS PERFORMED AND IDENTIFIED THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO DEGRADED TRANSDUCER WITHIN THE ASSEMBLY. THE PT COMPONENT IS RESPONSIVE TO INPUT, HOWEVER THE OUTPUT DIFFERENTIAL VOLTAGE (ODV) IS NEAR THE MINIMUM ACCEPTABLE VALUE. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN CAREFUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE SUSPECT COMPONENT IS AVAILABLE FOR ANALYSIS AND A RETURN GOOD AUTHORIZATION (RGA) HAS BEEN ISSUED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT COMPONENT 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 EXHALATION DIFFERENTIAL PRESSURE TRANSDUCER FAILED CALIBRATION TESTING. THE ISSUE OCCURRED DURING PATIENT USE, THE CUSTOMER REPORTED THERE IS NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699851 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention