BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1190624 · Received October 6, 2008

    Report

    Report Number
    2031642-2008-00207
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXHALATION FLOW SENSOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM; HOWEVER, THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY THAT INDICATED A VENT INOP OCCURRED DUE TO A FLOW SENSOR FAILURE. THE SERVICE TECHNICIAN REPLACED THE EXHALATION FLOW SENSOR AS A PRECAUTION. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED PER OPERATING SPECIFICATIONS.

    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 UNK HME| DISPOSABLE PATIENT CIRCUIT| SPU EXPIRATORY FILTER