BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA XL

    MDR report key: 2233322 · Received August 31, 2011

    Report

    Report Number
    2233322
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 31, 2011
    Manufacturer
    DRAEGER
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS UNPLUGGED IN PREPARATION FOR PATIENT TRANSPORT. IT GAVE AN APPROPRIATE EXTERNAL BATTERY ALARM, WHICH WAS RESET PER PROCEDURE. A FEW MINUTES LATER, THE VENTILATOR ALARMED AGAIN AND WAS SILENCED. RT NOTED THE VENTILATOR WAS RUNNING ON INTERNAL BATTERY WHICH LASTS ONLY 3 MINUTES. WHILE LEAVING THE UNIT, THE VENTILATOR POWER SHUT DOWN COMPLETELY. THE PATIENT WAS HAND-BAGGED FOR THE DURATION OF TRANSPORT AND MAINTAINED OXYGEN SATURATIONS DURING THE TRANSITION.CLINICAL ENGINEERING INVESTIGATION FOUND THAT THE BATTERIES ON THE VENTILATOR WERE EXHAUSTED AND WOULD NO LONGER ACCEPT A CHARGE. IT IS SUSPECTED THAT THIS IS DUE TO IMPROPER CHARGING PROTOCOL. EQUIPMENT IS DIFFICULT TO CHARGE PROPERLY AS IT IS REQUIRED TO BE PLUGGED IN AND TURNED ON IN ORDER TO CHARGE. MOST STAFF ASSUME THAT WHEN NOT IN USE, SIMPLY PLUGGING IN IS SUFFICIENT TO CHARGE THE BATTERY, AND ACCORDING TO THE MANUFACTURER, THIS IS NOT THE CASE. WE BELIEVE THE METHOD OF CHARGING SHOULD BE CONGRUENT WITH THE REST OF HOSPITAL EQUIPMENT, AND NOT REQUIRE THE MACHINE TO BE TURNED ON IN ORDER TO CHARGE THE BATTERY.THE FACILITY CURRENTLY HAS A FLEET OF 55 EVITA XL VENTILATORS WHICH WERE PURCHASED APPROXIMATELY 2 YEARS AGO. AT PEAK CENSUS LEVELS, THE VENTILATORS ARE IN USE AND THE LACK OF BATTERY CHARGING IS NOT A CONCERN. HOWEVER WHEN THE CENSUS IS LOW, MANY VENTILATORS ARE IN STORAGE AND DEEP DISCHARGE OF BATTERIES BECOMES A RELEVANT CONCERN. THOUGH THE USER MANUAL SPECIFIES THE DEVICE AC MAIN SWITCH MUST BE TURNED ON IN ORDER FOR THE EXTERNAL BATTERIES TO CHARGE, THIS IS NOT TYPICAL OF MEDICAL EQUIPMENT, AND THERE ARE INSTANCES IN WHICH STAFF PLUG THE EQUIPMENT IN, BUT DO NOT TURN ON THE AC SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA XL VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER EVITA XL *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR