BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPIRIT VENTILATOR

    MDR report key: 883705 · Received July 20, 2007

    Report

    Report Number
    2031642-2007-00110
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    June 28, 2007
    Report Date
    June 28, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE VENTILATOR WAS FAILING SHORT SELF TEST (SST) DUE TO SAFETY VALVE OPEN (SVO). THE UNIT BEING TESTED, THEREFORE THERE WAS NO PT INVOLVEMENT OR HARM, AND ALARMS WERE NOT APPLICABLE. THE RESPIRONICS SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE SST TEST FAILURE. THE SERVICE TECHNICIAN PERFORMED BACK PRESSURE TESTING OF THE EXPIRATORY FILTER. THE SERVICE TECHNICIAN REPORTED, THE BACKPRESSURE TEST OF THE EXPIRATORY FILTER MEASURED 87CM H20 PRESSURE. INDICATING A GROSS OCCLUSION. THE TEST SPECIFICATION IS <4CMH2O. 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 EXPIRATORY FILTER TO CORRECT THE PROBLEM. EXTENDED SELF TESTING (EST) WAS PERFORMED 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. THE CUSTOMER WAS INFORMED OF THE SERVICE TECHNICIAN'S FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPIRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR REUSABLE EXPIRATORY FILTER