BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100

    MDR report key: 24968597 · Received April 23, 2026

    Report

    Report Number
    2518422-2026-112525
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 13, 2024
    Report Date
    April 23, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959022751
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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. THE REPORTED FAILURE OF FAILED TEST FOR ACT EXH PURGE VALVE CLOSED AND ACT EXH PROPORT VALVE OPENED IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION PATIENT EXPOSURE TO FUNCTION / DETERIORATION OF FUNCTION. COMPLAINTS FOR THIS FAILURE ARE REVIEWED VIA THE POST MARKET COMPLAINT TRENDING AND ESCALATION PROCESSES TO ASSESS FOR THE OBSERVED PROBABILITY LEVELS AND COMPARE THEM WITH THE PREDICTED LEVELS IN THE RISK FILE FOR THE HAZARDS LINKED TO THE FAILURE. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAS LED TO UNACCEPTABLE INCREASE IN PROBABILITY LEVELS FOR THE HAZARDOUS SITUATIONS IN SCOPE, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. QA CONTINUES TO MONITOR COMPLAINTS FOR THIS ISSUE PER THE CADENCE IN THE COMPLAINT TRENDING PROCEDURES.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR ACT EXH PURGE VALVE CLOSED AND ACT EXH PROPORT VALVE OPENED DURING TESTING. THE FOAM WAS INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029230 TRILOGY100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054097 00606959022751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown