BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY 100

    MDR report key: 4202980 · Received October 23, 2014

    Report

    Report Number
    2518422-2014-01860
    Event Type
    Death
    Date Received
    October 23, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    RESPIRONICS INC.,
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVAL. A REVIEW OF THE DEVICE'S ERROR LOG INDICATED A VENTILATOR INOPERATIVE CONDITION OCCURRED ON (B)(6) 2014 AT 22:32:15 PM. THE VENTILATOR WAS RESTARTED 50 SECONDS LATER AT 22:33:05 PM AND OPERATED NORMALLY UNTIL 00:56 AM ON (B)(6) 2014, AT WHICH TIME IT WAS MANUALLY TURNED OFF. THE ERRORS WHICH WERE LOGGED FOR THE VENTILATOR INOPERATIVE CONDITION WERE RELATED TO TRANSIENT REBOOT ISSUES WITH THE DEVICE'S SYSTEM PCA. THE SYSTEM PCA WAS REPLACED TO ADDRESS THE ISSUE. AS A LIFE SUPPORT DEVICE, TRILOGY IS DESIGNED TO ENSURE THAT IT IS OPERATING PROPERLY AND DELIVERING THE NEEDED THERAPY. TRILOGY IS ALSO DESIGNED TO RECOVER FROM TRANSIENT UPSETS QUICKLY AND SAFELY TO MAINTAIN CONTINUITY OF THERAPY. THE MECHANISM TO RECOVER FROM TRANSIENT UPSETS IS A DEVICE REBOOT, WHICH IN THIS CASE TOOK PLACE AS DESIGNED. BASED ON THE AVAILABLE INFO AND TESTING, THE MANUFACTURER CONCLUDES THAT ALTHOUGH A VENTILATOR INOPERATIVE CONDITION OCCURRED 2 HOURS AND 23 MINS PRIOR TO THE REPORTED EVENT, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED PT OUTCOME.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING A PT EXPIRED WHILE ON A VENTILATOR. ACCORDING TO THE REPORTER OF THE EVENT, ON (B)(6) 2014, THE DEVICE EXPERIENCED A VENTILATOR INOPERATIVE CONDITION AND ALARMED AT APPROXIMATELY 10:30 OR 11:00 PM. THE CAREGIVER RESPONDED TO THE ALARM AND RESTARTED THE VENTILATOR IMMEDIATELY. THE VENTILATOR THEN OPERATED NORMALLY, WITH NO ALARMS OR EVENTS, UNTIL THE PT EXPIRED AT APPROXIMATELY 2:00 AM ON (B)(6) 2014. THE REPORTER OF THE EVENT STATED THAT THE DEICE DID NOT CAUSE THE EVENT. THE PT, AN ELDERLY FEMALE, WAS TERMINALLY ILL AND NOT EXPECTED TO SURVIVE. A BACKUP DEVICE WAS NOT IN THE PT'S HOME AT THE TIME OF THE REPORTED VENTILATOR INOPERATIVE CONDITION. LABELING FOR THE TRILOGY 100 STATES THE FOLLOWING: "FOR VENTILATOR DEPENDENT PATIENTS, ALWAYS HAVE ALTERNATE VENTILATION EQUIPMENT, SUCH AS A BACK-UP VENTILATOR, MANUAL RESUSCITATOR, OR SIMILAR DEVICE, AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676356 TRILOGY 100 CBK RESPIRONICS INC., 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1 Death