BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2160446 · Received July 13, 2011

    Report

    Report Number
    2031642-2011-00222
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS DISPLAYING ERRORS DURING DIAGNOSTICS TESTING. THERE WAS NO PATIENT INVOLVEMENT AS THE VENTILATOR WAS NOT IN USE AT THE TIME OF THE REPORTED PROBLEM. DURING EVALUATION OF THE UNIT, THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE AND OBSERVED THE 10A FUSE ON THE POWER SUPPLY HAD FAILED. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY FUSE TO ADDRESS THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS. FAILURE OF THE 10A POWER SUPPLY FUSE MAY RESULT IN A LOSS OF AC POWER IF IT OCCURRED DURING USE. IF A LOSS OF AC OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN, 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