BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3902413 · Received June 30, 2014

    Report

    Report Number
    2031642-2014-00573
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT CYCLE ON AND WAS CONTINUOUSLY BEEPING. 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) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED THE VENTILATOR WOULD RUN ON BATTERY POWER BUT NOT ON AC POWER. THE FSE REPLACED THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380161 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1