BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 24718821 · Received March 30, 2026

    Report

    Report Number
    2518422-2026-111616
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 11, 2024
    Report Date
    March 27, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959022744
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS RETURNED TO THE SERVICE CENTER, DURING FUNCTIONAL TESTING, THE DEVICE FAILED DUE TO A LOW FLOW CONDITION. REWORK WAS INITIATED, INCLUDING ADDING HLR, BI1, AND F1 STEPS FOR RETESTING; HOWEVER, NO REPAIRS WERE COMPLETED AS THE CUSTOMER REQUESTED THE UNIT BE RETURNED UNSERVICED. VISUAL INSPECTION DID NOT IDENTIFY ANY CONTAMINATION OR SIGNIFICANT ABNORMALITIES. DURING EVALUATION, AN ERROR CODE WAS OBSERVED, INDICATING A NEED TO CHECK INTERNAL TUBING. ADDITIONAL FINDINGS INCLUDED MISSING RUBBER FEET AND WORN HANDLE O-RINGS REQUIRING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781733 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054096 00606959022744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown