BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 935606 · Received October 31, 2007

    Report

    Report Number
    2031642-2007-00183
    Event Type
    Other
    Date Received
    October 31, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 2, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR FAILED THE SAFETY VALVE TEST DURING EXTENDED SELF TESTING (EST). THE VENTILATOR WAS NOT IN USE ON A PT, THEREFORE, THERE WAS NO PT HARM OR INVOLVEMENT. THE RESPIRONICS SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. EST WAS PERFORMED AND THE UNIT PASSED TO OPERATING SPECIFICATIONS. REVIEW OF THE DIAGNOSTIC CODE LOG CONFIRMED THE UNIT FAILED SHORT SELF TESTING (SST) DUE TO SAFETY VALVE CANNOT OPEN. THE SERVICE TECHNICIAN REPORTED THE EXPIRATORY FILTER WAS FULL OF WATER. FAILURE TO OPEN SAFETY VALVE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION OCCURRED DURING PT USE. FILTER REPLACEMENT MUST BE PERFORMED AT MANUFACTURER RECOMMENDED INTERVALS. USER MAINTENANCE CONTRIBUTED TO THIS EVENT DUE TO AN OCCLUDED FILTER.

    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 NA YR