BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4090660 · Received September 15, 2014

    Report

    Report Number
    2031642-2014-01035
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 18, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 VENTILATOR WAS ALARMING DUE TO A VENT INOP AIR VALVE LIFTOFF FAILURE. THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. DURING EVALUATION, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) FOUND THE BLOWER WOULD NOT RUN WHEN CONNECTED TO AC POWER. REVIEW OF THE DIAGNOSTIC HISTORY LOG SHOWS A 1012 AIR VALVE LIFT-OFF FAILURE, A VENT INOP CONDITION. THE FSE REPLACED THE POWER SUPPLY TO RESOLVE THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569991 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1