BEUDAMED
    FDA Adverse Event Summary report: N

    AVEA

    MDR report key: 2112755 · Received May 30, 2011

    Report

    Report Number
    2112755
    Date Received
    May 30, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 30, 2011
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO SWITCH PATIENT FROM CONTINUOUS POSITIVE AIRWAY PRESSURE/PRESSURE SUPPORT VENTILATION (CPAP/PSV) ON THE AVEA TO PRESSURE CONTROLLLED/PRESSURE SUPPORT (PC/PS/S). ONCE IN THE MODE SCREEN IT FROZE, AND WOULD NOT ALLOW THE CHANGE. THE VENTILATOR WAS TURNED OFF 3 TIMES TO REBOOT, AND WAS FROZEN IN THE INTIAL SET-UP SCREEN. DURING THIS TIME, THE PATIENT WAS BAGGED AND THEN EXTUBATED TO A NASAL CANNULA. UNIT TURNED ON AND WENT THROUGH EXTENDED SELF TEST (EST) OK. ALL BUTTONS PERFORMED AS DESIGNED. PERFORMED OVT. ALL TESTS WERE WITHIN PARAMETERS. RAN UNIT FOR 8 HOURS WHILE CHANGING MODES AND PATIENT TYPES. NO FAULTS FOUND.ERROR LOG SHOWED 2 ALARMS. PNEUMATICS MODULE FTC AND IMPROPER POWER-DOWN. CONTACTED CAREFUSION. TECH SUPPORT SAID THAT THESE ERRORS DID NOT INDICATE ANY PARTICULAR PROBLEMS. TECH SUPPORT RECOMMENDATION WAS THAT THE PROBLEM WAS PROBABLY IN THE UIM: UIM = USER INTERFACE MODULE (DISPLAY, MICROPROCESSOR, ASSOCIATED SOFTWARE). WE COULD EITHER MONITOR THE UNIT FOR ANOTHER OCCURRENCE OF THE PROBLEM OR REPLACE THE UIM WITH AN UPGRADED UNIT.RAN UNIT PERIODICALLY FOR 2 WEEKS. UNABLE TO DUPLICATE PROBLEM. RETURNING TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 207, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO