BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1031786 · Received April 15, 2008

    Report

    Report Number
    2031642-2008-00092
    Event Type
    Other
    Date Received
    April 15, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 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
    CT, 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 PT. THE CUSTOMER REPORTED THERE WAS NO PT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN PERFORMED BACK PRESSURE TESTING OF THE CUSTOMER'S REUSABLE EXHALATION FILTER. A BACK PRESSURE OVER 4 CMH2O INDICATES AN OCCLUDED FILTER. THE FILTER FAILS THE TEST IF THE BACK PRESSURE IS >4 CMH2O. THE SERVICE TECHNICIAN REPORTED THE TEST RESULTS MEASURED 4.8 CMH2O PRESSURE, INDICATING AN 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 CUSTOMER'S OCCLUDED EXPIRATORY FILTER. EXTENDED SELF TESTING (EST) WAS PERFORMED AND TESTS PASSED TO OPERATING SPECIFICATIONS. USER MAINTENANCE CONTRIBUTED TO THIS EVENT. 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 UNK