BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 24500234 · Received March 3, 2026

    Report

    Report Number
    2518422-2026-106059
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    July 14, 2024
    Report Date
    May 15, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959022751
    PMA / PMN Number
    K083526
    Removal / Correction Number
    Z-1956-2021
    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.

    Additional Manufacturer Narrative · 0

    ON PREVIOUSLY SUBMITTED REPORT, DESCRIBE EVENT OR PROBLEM SECTION WAS INCORRECT. THE UPDATED/CORRECTED ONE WILL BE: 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 A TEST STEP FOR OXYGEN LOW FLOW DURING TESTING. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED. THE FOLLOWING SECTIONS: (DEVICE) PROBLEM CODE GRID, HEALTH IMPACT GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID, CONCLUSION CODE GRID, REMEDIAL ACTION INIT (RFB), RECALL (Z) NUMBER (RFB) ARE UPDATED/CORRECTED IN THIS FOLLOW-UP REPORT. 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 TEST STEP FOR OXYGEN LOW FLOW DURING TESTING 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

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED. HOWEVER, THE DEVICE FAILED THE OXYGEN LOW FLOW TEST DURING FINAL TESTING. ADDITIONALLY, THERE IS DUST ON THE BLOWER BOX, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. THE UNIT GOING TO HLR FOR FURTHER REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237692 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054097 00606959022751

    Patients

    Seq Age Sex Outcome Treatment
    1