BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2534189 · Received April 12, 2012

    Report

    Report Number
    2031642-2012-00163
    Event Type
    Death
    Date Received
    April 12, 2012
    Date of Event
    March 25, 2012
    Report Date
    March 28, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RESPIRATORY CARE DIRECTOR REPORTED THE FOLLOWING: PRIOR TO BEING PUT ON THE VENTILATOR THE FEMALE PATIENT HAD SUFFERED A STROKE AND WAS IN AN ACUTE CARE FACILITY. SHE DEVELOPED ARDS AND WAS PUT ON THE VENTILATOR WITH SETTINGS AT THE TIME OF EVENT OF FIO2 45%, A/C 12. WHEN THEY TRIED TO VENTILATE WITH SIMV HER SPONTANEOUS RESPIRATIONS WOULD INCREASE, SO THEY WOULD HAVE TO PUT HER BACK ON A/C. RECENT CHEST X-RAYS SHOWED SOME IMPROVEMENT. ON (B)(6) 2012 THE RESPIRATORY CARE DIRECTOR HEARD THE VENTILATOR ALARMING. UPON ENTERING THE PATIENTS ROOM SHE OBSERVED THE VENTILATOR WASN'T VENTILATING AND THERE WAS A SAFETY VALVE OPEN MESSAGE IN THE ALARM MESSAGE BOX. THE PATIENT'S OXYGEN SATURATION HAD DECREASED FROM 100% INTO THE LOW 90'S. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED AT 100% WITH OXYGEN SATURATION INCREASING. THE VENTILATOR WAS REMOVED FROM USE AND THE PATIENT WAS PLACED ON ANOTHER DEVICE AT THE SAME SETTINGS. DURING THE NIGHT THE PATIENT HAD TROUBLE WITH HER BLOOD PRESSURE AND THE NEXT MORNING (B)(6) 2012, THE PATIENT DETERIORATED. THE FAMILY DECIDED TO HONOR THE PATIENTS WISHES PER HER LIVING WILL AND THE PATIENT WAS REMOVED FROM THE VENTILATOR AND THEN EXPIRED. THE RESPIRATORY CARE DIRECTOR REPORTED THE PATIENT DID NOT SUSTAIN ANY PERMANENT HARM AS A RESULT OF THE OBSERVED SAFETY VALVE OPEN, AND THE PATIENT WAS REMOVED FROM THE VENTILATOR DUE TO THE STROKE AND PATIENT WISHES. THE VENTILATOR THAT WAS REMOVED FROM USE ON (B)(6) 2012, WAS EVALUATED AND TESTED BY THE MANUFACTURER'S SERVICE TECHNICIAN. THE SERVICE TECHNICIAN REPORTED IT PASSED INITIAL EXTENDED SELF TESTING, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED AN OCCURRENCE OF AN OCCLUSION SAFETY VALVE OPEN ALARM ON (B)(6) 2012. APPLICABLE TESTING WAS PERFORMED AND PASSED TO SPECIFICATIONS. THE SERVICE TECHNICIAN REPLACED THE 3 STATION SOLENOID AS A PRECAUTION. FACTORY ANALYSIS OF THE 3 STATION SOLENOID FOUND NO FAULTS DURING TESTING.

    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 Death