BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY EVO

    MDR report key: 18483169 · Received January 10, 2024

    Report

    Report Number
    2518422-2024-01612
    Event Type
    Death
    Date Received
    January 10, 2024
    Date of Event
    December 17, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959051942
    PMA / PMN Number
    K181166
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS PREVIOUSLY REPORTED: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DEATH OCCURRED WHILE USING THE TRILOGY EVO VENTILATOR. THE PATIENT HAD PASSED AWAY ON THE VENTILATOR AND THE PATIENT'S CAREGIVER, THE WIFE, WAS CONCERNED THAT THE VENTILATOR DID NOT ALARM. IT WAS REPORTED THAT THE PATIENT WAS ON AVAPS-AE AND ALL THE ALARMS WERE TURNED OFF. THE DEVICE SETTINGS AT THE TIME OF THE INCIDENT WERE PASSIVE AVAPS-AE VT 450 MAX P 20 EPAP MIN 6 MAX 10 AVAPS SPEED 5 PS MIN 5 MAX 10 RR 12 ITIME 1.0 RISE 3 TRIGGER AUTO TRAK 4L O2 UNDER MASK. THE THERAPY DATA AND ALARM/EVENT LOG WERE RETRIEVED. THE PATIENT'S TIDAL VOLUME AND MINUTE VENTILATION HAD SIGNIFICANTLY DECREASED, TIDAL VOLUME WAS AROUND 100MLS. THE PATIENTS EPAP WAS AT THE MINIMUM SETTING OF 5CMH2O AT THIS TIME AND THEIR PS WAS AT ITS MAX OF 10CMH2O. IT WAS STATED THAT ALL SETTABLE ALARMS WERE TURNED OFF, NO CIRCUIT DISCONNECT ALARM, NO RESPIRATORY RATE ALARM, NO TIDAL VOLUME, NO MINUTE VENTILATION. THE PRESSURES THE VENTILATOR WAS DELIVERING WERE WITHIN THE EXPECTED PRESSURE AND THAT THE VENTILATOR FUNCTIONED PROPERLY. THE ER NOTES STATED THAT THE POLICE OFFICER NOTIFIED THE DOCTOR, AND IT WAS DEEMED NATURAL DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE EVO DEVICE WAS RETURNED TO THE PHILIPS INVESTIGATION LAB FOR EVALUATION DUE TO "PATIENT PASSED AWAY ON TRILOGY EVO". THE DEVICE WAS RUN AND TESTED ON THE TRILOGY EVO TEST STATION. IN THE EVENT LOG, IT WAS OBSERVED THAT THE DEVICE WAS TURNED ON AND OFF AND THEN ALARMED FOR LOW EXPIRATORY PRESSURE. THE DEVICE WAS TESTED ON THE TRILOGY EVO MULTI-FUNCTION TEST STATION AND PASSED ALL APPLICABLE TEST STEPS. PHILIPS INVESTIGATION LAB WAS UNABLE TO DUPLICATE ANY FAILURE AND HAS DETERMINED THAT THE TRILOGY EVO FUNCTIONS AS DESIGNED. BASED OFF THE INFORMATION PROVIDED AND CURRENTLY AVAILABLE, FORESEEABLE UNINTENTIONAL USE ERROR: FAILURE TO APPROPRIATELY SET PATIENT THERAPY ALARMS WAS NOTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DEATH OCCURRED WHILE USING THE TRILOGY EVO VENTILATOR. THE PATIENT HAD PASSED AWAY ON THE VENTILATOR AND THE PATIENT'S CAREGIVER, THE WIFE, WAS CONCERNED THAT THE VENTILATOR DID NOT ALARM. IT WAS REPORTED THAT THE PATIENT WAS ON AVAPS-AE AND ALL THE ALARMS WERE TURNED OFF. THE DEVICE SETTINGS AT THE TIME OF THE INCIDENT WERE PASSIVE AVAPS-AE VT 450 MAX P 20 EPAP MIN 6 MAX 10 AVAPS SPEED 5 PS MIN 5 MAX 10 RR 12 ITIME 1.0 RISE 3 TRIGGER AUTO TRAK 4L O2 UNDER MASK. THE THERAPY DATA AND ALARM/EVENT LOG WERE RETRIEVED. THE PATIENT'S TIDAL VOLUME AND MINUTE VENTILATION HAD SIGNIFICANTLY DECREASED, TIDAL VOLUME WAS AROUND 100MLS. THE PATIENTS EPAP WAS AT THE MINIMUM SETTING OF 5CMH2O AT THIS TIME AND THEIR PS WAS AT ITS MAX OF 10CMH2O. IT WAS STATED THAT ALL SETTABLE ALARMS WERE TURNED OFF, NO CIRCUIT DISCONNECT ALARM, NO RESPIRATORY RATE ALARM, NO TIDAL VOLUME, NO MINUTE VENTILATION. THE PRESSURES THE VENTILATOR WAS DELIVERING WERE WITHIN THE EXPECTED PRESSURE AND THAT THE VENTILATOR FUNCTIONED PROPERLY. THE ER NOTES STATED THAT THE POLICE OFFICER NOTIFIED THE DOCTOR, AND IT WAS DEEMED NATURAL DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552406 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2110X11B 00606959051942

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death