BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2100966 · Received May 24, 2011

    Report

    Report Number
    2031642-2011-00155
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    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

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF A RETURNED POWER SUPPLY REVEALED A MALFUNCTION THAT MAY RESULT IN THE UNIT SHUTTING DOWN DURING 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
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1