BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA XL

    MDR report key: 2223387 · Received August 17, 2011

    Report

    Report Number
    2223387
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 17, 2011
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING VENTILATOR TREATMENT, THE RESPIRATORY CARE PRACTITIONER (RCP) DISCONNECTED THE VENTILATOR TO PERFORM AN ENDOTRACHEAL TUBE (ET) TUBE TO TRACHEAL TUBE EXCHANGE ON THE PATIENT. WHILE ATTEMPTING TO RE-CONNECT THE VENTILATOR TO THE PATIENT AND RE-ESTABLISH THERAPY, THE VENTILATOR GAVE A "FLOW MEASUREMENT FAILURE" ERROR. THE RCP TRIED WITHOUT SUCCESS TO RE-CALIBRATE THE FLOW SENSOR. THE VENTILATOR WAS REMOVED AND EXCHANGED WITH A WORKING DEVICE AND THE FAILED UNIT WAS SENT TO BIOMEDICAL FOR REPAIR. BIOMEDICAL DETERMINED THAT THE FAILURE WAS CAUSED BY A DEFECTIVE INTERNAL FLOW SENSOR CABLE HARNESS. THE HARNESS ASSEMBLY WAS REPLACED AND THE VENTILATOR PASSED THE USER VERIFICATION TEST AND FLOW AND VOLUME DATA WAS VALIDATED. THE HARNESS IS AN INTERNAL NON-USER SERVICABLE PART. THE VENTILATOR HAS TO BE DISASSEMBLED TO GAIN ACCESS TO THIS ASSEMBLY PART. ONE END OF THE HARNESS IS USED AS THE PLUG-IN RECEPTICAL FOR THE DISPOSABLE FLOW SENSOR THAT IS EXCHANGED ON EVERY USE. EITHER THE PINS ARE BEING WORN LOOSE OR THE CABLE FLEXES DUE TO THE FLOW SENSOR HAVING TO SLIDE THREE-QUARTERS OF AN INCH TO SEAT THE SENSOR. DRAGER JUST STARTED INCLUDING THIS ASSEMBLY AS ONE OF THE PARTS IN THE 6 YEAR PREVENTIVE MAINTENANCE KIT. THIS PART HAS BEEN REPLACED BEFORE FOR THE SAME ISSUES OR BY NOT PASSING PERFORMANCE TESTING. WE HAD AN ADDITIONAL FAILURE OF THIS CABLE HARNESS ASSEMBLY IN THE LAST WEEK WHERE ONE OF THE PINS WAS PUSHED BACK INTO THE CONNECTOR ASSEMBLY.======================MANUFACTURER RESPONSE FOR VENTILATOR, INTENSIVE CARE, EVITA XL (PER SITE REPORTER)======================MANUFACTURER REQUESTING RETURN OF DEFECTIVE FLOW SENSOR CABLE HARNESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *