BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3945650 · Received July 7, 2014

    Report

    Report Number
    2031642-2014-00626
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 11, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION AN REPAIR.

    Additional Manufacturer Narrative · 1

    RECEIVED BY MFG DATE: 02/27/2015. CONCLUSION / ROOT CAUSE: THIS POWER SUPPLY WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE VENT INOP. EVALUATION AND REPAIR BY THE MFR'S FIELD SERVICE ENGINEER IS PENDING. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PT.

    Description of Event or Problem · 1

    THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) REPORTED INITIAL INSPECTION NOTED A VENT INOP OCCURRENCE DUE TO AN AIR VALVE LIFTOFF FAILURE. THE VENT INOP INDICATOR SIGNALS THE OPERATOR THAT THE VENTILATOR IS NOT CAPABLE OF SUPPORTING VENTILATION AND REQUIRES SERVICE. THE FSE COULD NOT VERIFY NO FLOW DURING EVALUATION. FINAL TESTING OF THE DEVICE PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393193 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1