BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6143336 · Received December 2, 2016

    Report

    Report Number
    2021710-2016-04973
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 4, 2016
    Report Date
    September 20, 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

    IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT MAIN PRINTED CIRCUIT BOARD ASSEMBLY FOR INVESTIGATION. AN INVESTIGATION WAS PERFORMED; THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED OR DUPLICATED IN A LABORATORY SETTING.

    Additional Manufacturer Narrative · 1

    THE VYAIRE MEDICAL FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT, A VELA TURBINE, AND EVALUATED THE DEVICE. AN EVALUATION OF THE COMPONENT DUPLICATED THE REPORTED ISSUE AND FOUND THAT THE TURBINE CHARACTERIZATION WAS NO LONGER VALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIDAL VOLUME (VT) WAS OUT OF RANGE. THE EXHALED VOLUME (VTE) WAS 741 WHILE THE SET VALUE WAS 500 ML AND MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCB) EXHL FLOW TRANSDUCER FAILED THE 3 CMH2O CALIBRATION. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793481 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention