BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 7115588 · Received December 13, 2017

    Report

    Report Number
    2021710-2017-07132
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 13, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL COMPLAINT NUMBER (B)(4). RESULTS OF INVESTIGATION: A VYAIRE MEDICAL FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE. THE FSR WAS UNABLE TO DUPLICATE THE REPORTED LOW INLET ALARM. THE FSR FOUND THAT THE VENTILATOR FAILED THE LEAK TEST AND EXHALATION VALVE CHARACTERIZATION. THE FSR FOUND THAT THE EVENTS LOG INCLUDED "MOTOR FAULT" AND "VENT INOP" ALARMS. THE FSR REPLACED THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND TURBINE ASSEMBLY. THE FSR PERFORMED THE EXTENDED SYSTEMS TEST AND THE OPERATIONAL VERIFICATION PROCEDURE. THE DEVICE MEETS MANUFACTURER'S SPECIFICATIONS. THE VYAIRE MEDICAL FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENTS, A VELA MAIN PCBA AND A VELA TURBINE ASSEMBLY, FOR EVALUATION. AN EVALUATION OF THE MAIN PCBA DUPLICATED THE REPORTED ISSUE AND ISOLATED THE ISSUE TO A FAILED TRANSDUCER. AN EVALUATION OF THE TURBINE ASSEMBLY DID NOT DUPLICATE THE REPORTED ISSUE AND THE TURBINE OPERATED PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PRE USE CHECK, THE VENTILATOR HAS AN O2 INLET ERROR ALARM. THE O2 INLET MONITORED VALUE WAS READING BETWEEN 20-45. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892568 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1