BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3895566 · Received June 25, 2014

    Report

    Report Number
    2031642-2014-00556
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: 8/20/2014. CONCLUSION / ROOT CAUSE: THE THREE STATION SOLENOID WAS TESTED AND NO FAILURES WERE IDENTIFIED. THE REPORTED ERROR COULD NOT BE DUPLICATED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR FAILED PRE-OPERATIONAL SYSTEM PRESSURE TESTING. THE MANUFACTURER'S SERVICE ENGINEER REPLACED THE 3 STATION SOLENOID TO CORRECT THE PROBLEM. IF THE SOLENOID MALFUNCTIONS DURING NORMAL VENTILATION USAGE, IT MAY RESULT IN A SUSTAINED SAFETY VALVE OPEN OCCURRENCE. 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. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370096 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1