BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1904458 · Received November 22, 2010

    Report

    Report Number
    2031642-2010-00299
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB); SOLENOID.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR FAILED PRE-OPERATIONAL TESTING OF THE VENTILATOR DUE TO AN INHALATION AUTOZERO SOLENOID FAILURE. THERE WAS NO PATIENT 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 PATIENT, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE SERVICE TECHNICIAN REPLACED THE SENSOR BOARD AND THREE STATION SOLENOID TO CORRECT THE PROBLEM. EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO 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