BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6201456 · Received December 22, 2016

    Report

    Report Number
    2021710-2016-05088
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 3, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT MAIN PRINTED CIRCUIT BOARD ASSEMBLY FOR INVESTIGATION. AN INVESTIGATION WAS PERFORMED AND THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE J2 LCD DISPLAY CONNECTOR WAS FOUND MISSING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE VELA VENTILATOR; THE UNIT DISPLAYS A TRANSDUCER FAULT ALARM. THE CUSTOMER REPORTED THE EXHALATION PRESSURE TRANSDUCER FAILED CALIBRATION TESTING. THE ISSUE OCCURRED DURING PATIENT USE; THE CUSTOMER REPORTED THE VENTILATOR WAS SUBSTITUTED WITH ANOTHER VENTILATOR. THE CUSTOMER REPORTED THERE IS NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE VELA VENTILATOR; THE UNIT DISPLAYS A TRANSDUCER FAULT ALARM. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848614 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention