BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 922274 · Received October 3, 2007

    Report

    Report Number
    2031642-2007-00161
    Event Type
    Other
    Date Received
    October 3, 2007
    Date of Event
    September 6, 2007
    Report Date
    September 6, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING OCCLUSION SAFETY VALVE OPEN (SVO) WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE RESPIRONICS SERVICE TECHNICIAN CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN PERFORMED BACK PRESSURE TESTING OF THE EXHALATION FILTER. THE SPECIFICATION IS 5-15CMH20. THE SERVICE TECHNICIAN REPORTED THE TEST RESULTS MEASURED 13CM420 PRESSURE, INDICATING AN OCCLUSION. AS SPECIFIED, A DETECTED OCCLUSION WILL CAUSE THE VENTILATOR TO ALARM AND OPEN THE SAFETY VALVE UNTIL THE VENTILATOR TO ALARM AND OPEN THE SAFETY VALVE UNTIL THE OCCLUSION IS RESOLVED. THE SERVICE TECHNICIAN REPLACED THE EXPIRATORY FILTER. EXTENDED SELF TESTING (EST) WAS PERFORMED AND TESTS PASSED TO OPERATING SPECIFICATIONS. USER MAINTENANCE CONTRIBUTED TO THIS EVENT DUE TO AN OCCLUDED FILTER. FILTER REPLACEMENT MUST BE PERFORMED PER MANUFACTURER RECOMMENDATIONS AND SPECIFIED INTERVALS.

    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 YR