BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 4780940 · Received May 14, 2015

    Report

    Report Number
    2021710-2015-00986
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: CAREFUSION TESTED AND EVALUATED THE DEFECTIVE COMPONENT, THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER'S REPORTED ISSUE. A REVIEW OF THE ERROR LOG HISTORY WAS REVIEWED AND THERE WERE NO NEW ERRORS RECORDED IN THE LOG HISTORY. THE SERVICE TECHNICIAN CHECKED THE TCA CALIBRATIONS UNDER THE CALIBRATION MENU AND DID NOT FIND ANY ANOMALIES. THE UNIT PASSED ALL TESTING'S.

    Additional Manufacturer Narrative · 1

    CAREFUSION HAS REQUESTED ADD'L INFO FROM THE USER FACILITY ON THE REPORTED EVENT AND THE STATUS OF THE PT. AS OF MAY 14, 2015 THERE HAS BEEN NO ADD'L INFO PROVIDED BY THE USER FACILITY. THE USER FACILITY BIOMED REPORTED THAT HE HAS NOT BEEN ABLE TO REPRODUCE/VERIFY THE REPORTED EVENT. THE CAREFUSION TECHNICAL SUPPORT SPECIALIST ADVISED THE USER FACILITY BIOMED THAT IT MIGHT BE ADVISABLE TO REPLACE THE DEVICE'S GAS DELIVERY ENGINE (GDE) AS A PRECAUTION. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE USER FACILITY FOR THE RETURN OF THE GAS DELIVERY ENGINE (GDE) FOR EVAL. AS OF MAY 14, 2015 THE GAS DELIVERY ENGINE (GDE) HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE ALARMED "VENT INOP" WHILE ON A PT. THEY ALSO REPORTED THAT THE PT REMOVED FOR THE DEVICE PLACED ON TO ANOTHER DEVICE AND THERE WAS NOT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316877 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention