BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 18334403 · Received December 15, 2023

    Report

    Report Number
    2518422-2023-35658
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 21, 2023
    Report Date
    September 1, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026322
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING THE DEVICE DID NOT MEET THE ACCEPTANCE CRITERIA OF THE EVALUATION PROCESS FOR THE FOLLOWING CONDITIONS: CRITICAL ERRORS (193, 290). ERROR 193 INTERNAL LI-ION BATTERY PERMANENT FAILURE. THE INTERNAL BATTERY IS THE FINAL POWER SOURCE. FAILURE OF THE INTERNAL BATTERY MAY IMPACT THERAPY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. ADDITIONAL INFORMATION FROM REPAIR EVALUATION: NO REPAIR PERFORMED DUE TO THE DEVICE NOT NEEDED FOR INVENTORY. THE UNIT WILL BE SCRAPPED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE DID NOT MEET THE ACCEPTANCE CRITERIA OF THE EVALUATION PROCESS FOR THE FOLLOWING CONDITIONS: CRITICAL ERRORS (193, 290). ERROR 193 INTERNAL LI-ION BATTERY PERMANENT FAILURE. THE INTERNAL BATTERY IS THE FINAL POWER SOURCE. FAILURE OF THE INTERNAL BATTERY MAY IMPACT THERAPY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. 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
    1041171 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. RSL1054260 00606959026322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown