BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPIRIT VENTILATOR

    MDR report key: 863912 · Received June 13, 2007

    Report

    Report Number
    2031642-2007-00097
    Event Type
    Injury
    Date Received
    June 13, 2007
    Report Date
    May 18, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST (RT) REPORTED THE FOLLOWING: ICU RN CALLED IN RT TO SUCTION PT DUE TO PT'S O2 SATURATION DECREASING AND RESPIRATORY RATE (RR) INCREASING. DURING SUCTIONING VIA CLOSED SUCTION SYS. RT OBSERVED RATE ON VENTILATOR TO INCREASE TO 80-120BPM WITH EXHALED VOLUMES APPROX, 200ML, PT'S SATURATION DECREASED FROM THE 90'S TO APPROX. 76%. PATIENT WAS REMOVED FROM VENT AND BAGGED BY RN. RT POWERED VENT OFF AND ON AND PLACED VENT BACK ON PT BUT VENT CONTINUED TO AUTO-CYCLE WITH RATE APPROX. 90. RT ADJUSTED VENT SENSITIVITY WITH NO CHANGE. CHANGED VENT MODE TO CPAP AND VENT CONTINUED TO CYCLE WITH HIGH RATE. RT PRESSED 100% O2 DELIVERY BUTTON BUT PT'S O2 SATURATION DECREASED INTO 60'S. REMOVED VENT FROM PT AND PLACED PT ON OTHER VENT AT SAME SETTINGS. VENT EXHIBITED NO AUTO-CYLING AND PT'S O2 SATURATION INCREASED INTO 90'S ON SET 40% FIO2 WITH PT LESS RESTLESS. RT REPORTED PT WAS BEING SUCTIONED EVERY 2 HOURS AT VENT CHECK. PT'S SPUTUM WAS THICK WITH SMALL PLUGS AND REQUIRED LAVAGE. RT INSPECTED VENT TAKEN OFF PT FOR CIRCUIT FOR LEAKS OR LOOSE CONNECTIONS AND REPORTED NONE. PT SUFFERED NO PERMANENT HARM OR ILL EFFECT. THE RESPIRONICS SVC TECH PERFORMED AN EVAL OF THE VENTILATOR AND WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM, AND FOUND NO DIAGNOSTIC CODES LOGGED IN VENTILATOR HISTORY RELATED TO THE REPORTED PROBLEM, PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED TO SPECIFICATION, INCLUDING O2 DELIVERY FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention HME AND BALLARD SUCTION SYSTEM