BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY 100

    MDR report key: 6259600 · Received January 18, 2017

    Report

    Report Number
    2518422-2017-00146
    Event Type
    Death
    Date Received
    January 18, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 6, 2017
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR DEPENDENT PATIENT EXPIRED. ACCORDING TO THE REPORTER OF THE EVENT, THE PATIENT WAS FOUND TO BE IN CARDIAC ARREST AND WAS TRANSPORTED TO A HOSPITAL WHERE SHE EXPIRED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE PASSED ALL TESTING AND WAS FOUND TO OPERATE AND ALARM AS DESIGNED. THE DEVICE'S AUDIBLE ALARM WAS FOUND TO MEET DECIBEL LEVEL SPECIFICATIONS. THE VENTILATOR'S DOWNLOADED EVENT LOG WAS REVIEWED. THE DEVICE MAINTAINS THE EVENT LOG 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 LOG WOULD HAVE CONTAINED ENTRIES RELATED TO THE MALFUNCTION. AT 22:09:35 UTC ON (B)(6) 2017, AC POWER WAS DISCONNECTED FROM THE DEVICE WHICH BEGAN OPERATING ON DETACHABLE BATTERY POWER AS DESIGNED. THE VENTILATOR OPERATED ON DETACHABLE BATTERY POWER UNTIL DEPLETION AT 02:02:2017 UTC ON (B)(6) 2017. AT THIS TIME, THE VENTILATOR BEGAN ALARMING TO ALERT THE CAREGIVER THAT THE DETACHABLE BATTERY WAS DEPLETED AND THE DEVICE WAS NOW OPERATING ON INTERNAL BATTERY POWER AS DESIGNED. THIS ALARM WAS ACKNOWLEDGED BY THE CAREGIVER AS EVIDENCED BY AN ALARM SILENCE/RESET KEYPRESS AT 02:14:58 UTC ON (B)(6) 2017. AC POWER WAS NOT RESTORED AT THIS TIME, AND THE DEVICE CONTINUED TO OPERATE ON INTERNAL BATTERY POWER. AT 04:43:05 UTC ON (B)(6) 2017, THE VENTILATOR SOUNDED A MEDIUM PRIORITY ALARM INDICATING THE INTERNAL BATTERY WAS DEPLETING. AT 04:52:37 UTC ON (B)(6) 2017, THE VENTILATOR SOUNDED A HIGH PRIORITY ALARM INDICATING THE INTERNAL BATTERY WAS NEARLY DEPLETED. THESE ALARMS WERE NOT ACKNOWLEDGED AND THE DEVICE POWERED OFF AT 05:04:09 UTC ON (B)(6) 2017 DUE TO DEPLETED BATTERIES. THE DEVICE WAS NOT POWERED ON AGAIN UNTIL 05:38:53 UTC ON (B)(6) 2017. THE MANUFACTURER CONCLUDES THE DEVICE OPERATED AS DESIGNED AND ALARMED APPROPRIATELY TO ALERT THE CAREGIVER OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45498 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death