BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 6031832 · Received October 14, 2016

    Report

    Report Number
    2021710-2016-04651
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 16, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). FIELD SERVICE REP EVALUATION: THE FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO EVALUATE THE SUSPECT DEVICE. THE FSE PERFORMED THE BATTERY RUN TEST WHICH PASSED AND EXCEEDING THE 30 MIN OF RUN TIME WITH COMPRESSOR RUNNING. THE INTERNAL BATTERY HARNESS, FUSE HOLDER, POWER CORD AND POWER SUPPLY VOLTAGE EVALUATED. AT THIS TIME, THE REPORTED EVENT WAS NOT DUPLICATED AND NO SPECIFIC COMPONENT HAS BEEN ISOLATED FOR A ROOT CAUSE INVESTIGATION. THE DEVICE CHARGED UP PROPERLY TO SPECIFICATIONS. THE FSE NOTED THAT THE CUSTOMER PLUGGED IN MULTIPLE DEVICES INTO THE SAME OUTLET, WHICH MAY HAVE RESULTED IN THE DECREASED CHARGE TO THE VENTILATOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THIS AVEA VENTILATOR NOT HOLDING AN INTERNAL BATTERY CHARGE AND CYCLING OFF. NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681585 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1