BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 868574 · Received June 21, 2007

    Report

    Report Number
    2031642-2007-00101
    Event Type
    Other
    Date Received
    June 21, 2007
    Date of Event
    May 24, 2007
    Report Date
    May 24, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT VENTILATOR WAS ALARMING OCCLUSION SAFETY VALVE OPEN (SVO) WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THE OCCLUSION SVO ALARM WAS ACTIVATING WHEN THEY RAN A HANDHELD NEBULIZER TREATMENT INLINE WITH THE PATIENT CIRCUIT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE RESPIRONICS SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN PERFORMED BACK PRESSURE TESTING OF THE EXHALATION FILTER. THE SPECIFICATION IS 5-15CMH2O. THE SERVICE TECHNICIAN REPORTED THE TEST RESULTS MEASURED 23CMH2O 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 DISCARDED THE EXPIRATORY FILTER AND INSTRUCTED THE CUSTOMER ON TESTING FILTERS. 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 UNK YR REUSABLE EXHALATION FILTER