BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 5980287 · Received September 27, 2016

    Report

    Report Number
    2021710-2016-04497
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    August 23, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREFUSION FIELD SERVICE REPRESENTATIVE EVALUATED THE UNIT AND DETERMINED THE ROOT CAUSE TO BE DUE TO A FAULTY MAIN BOARD. THE MAIN BOARD WAS REPLACED AND THE OPERATIONAL VERIFICATION TESTING WAS PERFORMED WHERE THE UNIT PASSED PER MANUFACTURING SPECIFICATIONS AND WAS PLACED BACK INTO SERVICE. IN THE EVENT THE MAIN BOARD IS RECEIVED FOR EVALUATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE FAILURE ANALYSIS LAB RECEIVED THE SUSPECT FAULTY MAIN PRINTED CIRCUIT BOARD FOR EVALUATION AND WAS ABLE TO REPRODUCE THE REPORTED FAILURE AND ISOLATE IT TO A FAULTY TRANSDUCER ON THE MAIN PRINTED CIRCUIT BOARD. THIS FAILURE IS PART OF AN INTERNAL INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THIS VENT WENT DOWN ON A PATIENT WITH THE MESSAGE "XDCR FAULT." THERE WAS NO HARM TO THE PATIENT, AND THE VENTILATOR WAS SWITCHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632478 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention