BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1053223 · Received May 28, 2008

    Report

    Report Number
    2031642-2008-00115
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DURING TESTING OF THE VENTILATOR AFTER INITIAL SETUP OF UNIT, THE MFR'S SERVICE TECH REPORTED THE UNIT FAILED EXTENDED SELF TESTING (EST) DUE TO AN INHALATION AUTOZERO SOLENOID FAILURE. THERE WAS NO PT INVOLVEMENT AND THEREFORE NO PATIENT HARM. IF THE SOLENOID MALFUNCTIONS AND CANNOT OPEN, THIS TASK CANNOT BE PERFORMED AND AFFECTS THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT. FAILURE OF THE AUTOZERO SOLENOIDS WHILE IN USE COULD RESULT IN A VENT INOP CONDITION. VENT INOP, IF IN USE ON A PT, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PT. THE SERVICE TECH REPLACED THE SENSOR BOARD TO CORRECT THE PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED, AND ALL TESTS PASSED TO OPERATING SPECS.

    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 NA