BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3864238 · Received June 10, 2014

    Report

    Report Number
    2031642-2014-00464
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 13, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT TURN ON VIA AC POWER AND THE MAINS POWER LED INDICATOR WAS NOT LIT. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPORTED PROBLEM. THE FSE REPLACED THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS AND PASSED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337611 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1