BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3841599 · Received May 30, 2014

    Report

    Report Number
    2031642-2014-00423
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR FAILED PRE-OPERATIONAL EXTENDED SELF TESTING (EST) DUE TO A LEAK AT THE INSPIRATORY NON-REBREATHING CHECK VALVE. THE MANUFACTURERS FIELD SERVICE ENGINEER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. UPON INSPECTION, THE SERVICE ENGINEER OBSERVED THE CHECK VALVE BODY WAS SEPARATED FROM THE OUTER RING, WHICH MAY RESULT IN BLOCKED AIRFLOW THROUGH THE GAS PATH OF THE ASSEMBLY. THE SERVICE ENGINEER REPLACED THE CHECK VALVE TO ADDRESS THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318659 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1