BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3941389 · Received July 17, 2014

    Report

    Report Number
    2031642-2014-00693
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR POWER SUPPLY FAILED. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED POWER SUPPLY FAILURE. DURING EVALUATION, THE FSE OBSERVED THE MAINS POWER LED INDICATOR WAS FLASHING AND AN ODOR OF OVERHEATING FROM THE POWER SUPPLY AREA. THE FSE REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF THE RETURNED POWER SUPPLY REVEALED A BRIDGE RECTIFIER SHORT THAT RESULTED IN THE REPORTED POWER ISSUE. EVALUATION OF THE COMPONENT NOTED HEAT RELATED DAMAGE. THE FAILURE AS NOTED MAY RESULT IN A LOSS OF AC POWER DURING NORMAL VENTILATION OPERATION. 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
    417940 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1