BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6012553 · Received October 7, 2016

    Report

    Report Number
    2021710-2016-04592
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE SUSPECT DEVICE. THE FSR CLEAN THE TOUCHSCREEN AND THE SURROUNDING FRAME. THE FSR RAN THE USER VERIFICATION TEST (UVT) AND CHECKED THE OPERATION OF THE DEVICE TO ENSURE IT IS WITHIN MANUFACTURER SPECIFICATION. NO PARTS WERE REPLACED AS THE DEVICE WORKED PROPERLY AFTER CLEANING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TOUCHSCREEN WAS NOT WORKING ON THEIR VELA VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663645 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1