BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 5482265 · Received March 5, 2016

    Report

    Report Number
    2021710-2016-03261
    Event Type
    Malfunction
    Date Received
    March 5, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 2016
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR DISCOVERED THAT THE REPORTED ALARMS WAS ACTUALLY A TRANSDUCER FAULT AND THE TOUCH SCREEN WAS LOCKING UP. IT IS CURRENTLY UNKNOWN WHICH TRANSDUCER WAS AFFECTED OR IF IT WAS AFFECTED BY THE TOUCHSCREEN LOCKING UP, BUT THE TOUCH SCREEN LOCKING UP IS A REPORTABLE EVENT. THE FSR HAS ORDERED REPLACEMENT PARTS TO COMPLETE HIS EVALUATION OF THE DEVICE AND IS AWAITING DELIVERY. ANY ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER OR FSE WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE. THE FSR FOUND A TRANSDUCER FAULT ERROR AND THAT THE TOUCH SCREEN LOCKED UP INTERMITTENTLY. THE FSR REPLACED THE MAIN BOARD AND COMPLETED PERFORMANCE TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE VELA VENTILATOR, IT WAS ALARMING EXT LER. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT ON A PATIENT AT THE TIME OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138678 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA COMP D

    Patients

    Seq Age Sex Outcome Treatment
    1