BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2173084 · Received July 23, 2011

    Report

    Report Number
    2031642-2011-00235
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL PRESSURE TUBINGS REPOSITIONED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT IS GIVING A LOW FLOW WHILE ON A PATIENT. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED PROBLEM WHEN RUNNING THE UNIT IN VENTILATION MODE. THE SERVICE TECHNICIAN REPORTED DURING EVALUATION OF THE DEVICE HE FOUND IN THE DIAGNOSTIC LOG AN SVO ERROR CODE. THE SERVICE TECHNICIAN OPEN THE DEVICE AND RE-ROUTED THE TUBING AND RETESTED THE VENT WITH PASSING RESULT. NO PART WAS REPLACED. KINKED TUBING COULD RESULT IN A SUSTAINED SAFETY VALVE OPEN OCCURRENCE DURING USE. WHEN THE SAFETY VALVE REMAINS OPEN, THE VENTILATOR IS NOT PROVIDING BREATH SUPPORT TO THE PATIENT. IT IS ACCOMPANIED BY AN ALARM AND A SAFETY VALVE OPEN MESSAGE IN THE DISPLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1