BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 5221115 · Received November 12, 2015

    Report

    Report Number
    2021710-2015-02187
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) RECEIVED THE PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) MAIN BOARD. THE CAREFUSION FA REP VISUALLY INSPECTED PART AND INSTALLED THE SUSPECT COMPONENT IN A KNOWN GOOD UNIT. THE CAREFUSION FA REP REPORTED THE MAIN BOARD CAME UP VENT INOP (INOPERABLE) ERRORS. THE EVENTS LOG RECORDED MULTIPLE MOTOR FAULTS, VENT INOP, XDCR (TRANSDUCER) FAULTS, AND EEPROM WRITE FAILURES, AND TRANSDUCER CALIBRATIONS DEFAULTED. THE CAREFUSION FA REP REPORTED THE EXHALATION DIFFERENTIAL XDCR CALIBRATION TEST FAILED. THE MALFUNCTIONING EXHALATION PRESS TRANSDUCER CAN CAUSE MOTOR FAULTS AND VENT INOP ERRORS. THE CAREFUSION FA REP DETERMINED THE ROOT CAUSE TO BE TRANSDUCER FAULTS AND ABOVE ARE KNOWN ISSUES, AND WERE CORRECTED INTERNALLY. THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) NOTED EEPROM WRITE FAILURES CAUSED BY DATA CABLE BEING DISCONNECTED FROM THE MAIN BOARD AND EX-PERIPHERAL INTERFACE BOARD.

    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 SUSPECT DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VENT INOP ALARMS WHILE USING THE VELA VENTILATOR. THE CUSTOMER PERFORMED CALIBRATIONS (LEAK TEST AND EXHALATION TEST), BUT ONLY TO HAVE REPEATED FAILURE. CAREFUSION (CFN) GLOBAL CARE SUPPORT CONFIRMED THE CUSTOMER HAD SEVERAL MOTOR FAULT ALARMS IN THE CUSTOMER EVENT LOG. THE CUSTOMER REPORTED THE FAULT FOUND WAS DURING TESTING AND NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750633 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA COMP D

    Patients

    Seq Age Sex Outcome Treatment
    1