BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3851612 · Received June 5, 2014

    Report

    Report Number
    2031642-2014-00448
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF THE RETURNED POWER SUPPLY REVEALED A CAPACITOR FAILURE THAT RESULTED IN THE REPORTED POWER ISSUE. THE NOTED FAILURE MAY RESULT IN THE UNIT SHUTTING DOWN DURING NORMAL VENTILATION OPERATION WHEN AC POWER IS RESTORED. IF A FAILURE OF THE POWER SUPPLY OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN DUE TO A LOSS OF AC POWER, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    Description of Event or Problem · 1

    DURING SERVICE OF THE VENTILATOR, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR WOULD NOT POWER ON AND THE MAINS POWER LED INDICATOR WOULD NOT ILLUMINATE. THE CUSTOMER DID NOT REPORT THE FINDING DURING PREVIOUS USAGE AND THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR HARM. THE FSE VERIFIED THERE WAS AC POWER TO THE POWER SUPPLY. THE FSE REPLACED THE POWER SUPPLY TO CORRECT THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328916 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1