BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 5478035 · Received March 3, 2016

    Report

    Report Number
    2021710-2016-03247
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 3, 2016
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE AND REPAIR THE DEVICE. A REPLACEMENT GAS DELIVERY ENGINE (GSE) WAS RECEIVED BY THE CUSTOMER AND INSTALLED BY THE CAREFUSION FSR. OPERATIONAL VERIFICATION PROCEDURES WERE PERFORMED PER CAREFUSION'S SERVICE MANUAL AND THE UNIT IS NOW WORKING PER MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE VENTILATOR ALARMED EXTENDED HIGH P PEAK AND CIRCUIT OCCLUSION AND AFTER THE CALIBRATION, THE VENT ALARMED LOW EXHALED VOLUME (VE) AND LOW FRACTION OF INSPIRED OXYGEN (FIO2). DURING THE REPORTED ISSUE THE VENT WAS NOT ON A PATIENT SO THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133282 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA COMP

    Patients

    Seq Age Sex Outcome Treatment
    1