BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 2795738 · Received September 25, 2012

    Report

    Report Number
    2795738
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    July 23, 2012
    Report Date
    September 20, 2012
    Manufacturer
    CAREFUSION 211, INC. DBA CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST (RT) RESPONDING TO VENTILATOR "CIRCUIT OCCLUSION" ALARM. VENT AND PATIENT CHECKED - NO PROBLEMS WITNESSED. THIS OCCURRED A FEW TIMES IN SEVERAL MINUTES WITH INCREASING FREQUENCY. RT MANUALLY VENTILATED PATIENT AND CONDUCTED CIRCUIT LEAK CHECK / EST (EXTENDED SELF TEST). VENT PASSED WITHOUT PROBLEMS. A VERY FAINT MUSICAL HARMONIC WAS HEARD COMING FROM THE VICINITY OF THE VENTILATOR EXHALATION VALVE. AT THIS TIME, MANUAL VENTILATION WAS CONTINUED AND THE VENTILATOR WAS REMOVED FROM THE PATIENT. A NEW MACHINE WAS CHECKED AND PLACED ON THE PATIENT. THE ALARM CONDITION CEASED. THE PATIENT APPEARED TO BE UNHARMED AND THE VENTILATOR WITH THE ALARM CONDITION WAS SAVED WITH ALL CIRCUITRY ATTACHED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 211, INC. DBA CAREFUSION AVEA *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA