BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 927998 · Received March 5, 2007

    Report

    Report Number
    2031642-2007-00052
    Event Type
    Other
    Date Received
    March 5, 2007
    Date of Event
    March 5, 2007
    Report Date
    March 5, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE VENTILATOR WAS ALARMING SAFETY VALVE OPEN (SVO) WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE RESPIRONICS SERVICE TECHNICIAN PERFORMED EXTENDED SELF TESTING, (EST) WHICH FAILED DUE TO THE HEATED FILTER BACK PRESSURE BEING OUT OF RANGE. THE SPECIFICATION IS 5-15CMH2O. THE SERVICE TECHNICIAN REPORTED, THE BACKPRESSURE TEST OF THE HEATED EXHALATION FILTER MEASURED 41CMH2O PRESSURE, INDICATING A GROSS OCCLUSION. AS SPECIFIED, A DETECTED OCCLUSION WILL CAUSE THE VENTILATOR TO ALARM AND OPEN THE SAFETY VALVE UNTIL THE OCCLUSION IS RESOLVED. THE SERVICE TECHNICIAN REPLACED THE REUSABLE EXPIRATORY FILTER TO CORRECT THE PROBLEM. EST WAS REPEATED AND PASSED TO OPERATING SPECIFICATIONS. USER MAINTENANCE CONTRIBUTED TO THIS EVENT DUE TO AN OCCLUDED FILTER. FILTER REPLACEMENT MUST BE PERFORMED AT MANUFACTURER RECOMMENDED 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 SINGLE PATIENT USE EXHALATION FILTER