BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5033734 · Received August 26, 2015

    Report

    Report Number
    2031702-2015-00189
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS AND PASSED THE INITIAL ALARM VOLUME TEST. DURING THE INITIAL FINAL TEST, THE VENTILATOR HAD A NON-CONFORMANCE WITH THE PORT-TO-PORT LEAK TEST. THE EXHALATION MODULE WAS REPLACED TO CORRECT THE NON-CONFORMANCE THAT WAS IDENTIFIED DURING SERVICE. THIS IS UNRELATED TO THE CUSTOMER'S REPORTED PROBLEM. A REVIEW OF THE EVENT TRACE FOUND THAT ON (B)(6) 2015, THE OPERATOR OF THE VENTILATOR SELECTED THE ¿PEDIATRIC¿ DEFAULT SETTING ON POWER UP. THE ¿PEDIATRIC¿ DEFAULT SETTING IS CONFIGURED FOR A ¿PRESSURE¿ BREATH TYPE. THE VENTILATOR REMAINED IN THIS VENTILATION MODE THROUGHOUT THE 4 HOUR OPERATION PERIOD. AT THE START OF THE NEXT SUBSEQUENT OPERATION PERIOD, THE OPERATOR OF THE VENTILATOR SELECTED THE ¿SAME PATIENT¿ DEFAULT SETTING ON POWER UP. THE VENTILATOR WOULD HAVE REMAINED CONFIGURED FOR THE PEDIATRIC DEFAULT ¿PRESSURE¿ BREATH TYPE SELECTED FOR IN THE PREVIOUS OPERATION PERIOD. ABOUT AN HOUR INTO THIS SUBSEQUENT OPERATION PERIOD THE EVENT TRACE INDICATES THE CUSTOMER CHANGED THE VENTILATOR BREATH TYPE TO ¿VOLUME¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VENTILATOR WAS SET UP IN VOLUME VENTILATION IT WENT INTO PRESSURE VENTILATION BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566436 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1