BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY 100

    MDR report key: 6124042 · Received November 23, 2016

    Report

    Report Number
    2518422-2016-04631
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 28, 2016
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS COMPLETED THE INVESTIGATION FOR A VENTILATOR THAT WAS ALLEGEDLY ASSOCIATED WITH A PATIENT DEATH. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE VENTILATOR PASSED ALL RELEVANT TESTING DURING EVALUATION AND WAS FOUND TO OPERATE AND ALARM AS DESIGNED. A TEST STEP WAS FAILED WHICH WAS RELATED TO THE VENTILATOR'S INFORMATION PORT WHICH IS USED TO CALIBRATE THE DEVICE AND DOES NOT IMPACT THERAPY OR DEVICE FUNCTION. THE DEVICE'S AUDIBLE ALARM FUNCTION WAS CONFIRMED TO BE WITHIN THE SPECIFIED DECIBEL LEVEL. THE DEVICE'S DOWNLOADED EVENTS LOGS AND PATIENT DATA LOGS WERE REVIEWED. THE DEVICE MAINTAINS THE EVENT LOGS IN NON-VOLATILE MEMORY. AN EVENT, AS LOGGED BY THE DEVICE, INCLUDES EVERY KEYPRESS, ALARM, OR FAILURE OF THE DEVICE TO REMAIN WITHIN SPECIFICATIONS. THERE WERE NO EVENTS LOGGED RELATED TO DEVICE PERFORMANCE OR DEVICE MALFUNCTIONS. IF A DEVICE MALFUNCTION OCCURRED, THE EVENT LOGS WOULD HAVE CONTAINED ENTRIES RELATED TO THE MALFUNCTION. THE REPORTED DATE OF THE EVENT WAS (B)(6) 2016. THE EVENT DATA FROM (B)(6) 2016 WAS USED TO DETERMINE THE FOLLOWING: THE EVENT LOGS INDICATE THE VENTILATOR BEGAN SOUNDING A HIGH PRIORITY LOW MINUTE VENTILATION ALARM AT 20:32:10 UTC WHICH CONTINUED TO SOUND FOR 1280 SECONDS (APPROXIMATELY 21 MINUTES). AT 20:32:25 UTC, A HIGH PRIORITY PATIENT CIRCUIT DISCONNECT ALARM WAS LOGGED WITH A DURATION OF 1265 SECONDS. THESE ALARMS WERE NOT ACKNOWLEDGED UNTIL 20:52:08 UTC. THE DEVICE WAS THEN POWERED OFF USING THE PROPER SEQUENCE OF KEYPRESSES AT 20:53:30 UTC. THE PATIENT DATA LOGS WHICH CONTAIN WAVEFORM ANALYSIS GRAPHS WERE REVIEWED. THE FLOW, LEAK AND EXHALED TIDAL VOLUME GRAPHS ARE CONSISTENT WITH THE SIGNIFICANT EVENT DATA ABOVE. AN INCREASE IN FLOW AND LEAK AT APPROXIMATELY 20:32 00 UTC INDICATE A PATIENT CIRCUIT DISCONNECT CONDITION OCCURRED. A LOSS OF EXHALED TIDAL VOLUME IS ALSO CONSISTENT WITH A PATIENT CIRCUIT DISCONNECT CONDITION. THESE CONDITIONS CONTINUED UNTIL THE DEVICE WAS POWERED OFF AT APPROXIMATELY 20:53:00 UTC. BASED ON TESTING AND EVALUATION OF THE VENTILATOR'S DOWNLOADED EVENT AND PATIENT DATA LOGS, THE MANUFACTURER CONCLUDES THE DEVICE OPERATED AND ALARMED AS DESIGNED DURING THE RELEVANT TIMEFRAME. A PATIENT CIRCUIT DISCONNECT CONDITION OCCURRED FOR APPROXIMATELY 21 MINUTES WITH THE DEVICE APPROPRIATELY ALARMING TO ALERT THE CAREGIVER OF THE CONDITION.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED WHILE ON A VENTILATOR. THE MANUFACTURER'S INVESTIGATION IS CURRENTLY 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
    774422 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death