BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 25032964 · Received April 29, 2026

    Report

    Report Number
    2518422-2026-011328
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 29, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Removal / Correction Number
    Z-1956-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCTS WITH FIELD COMPLAINTS ALLEGING PE-PUR FOAM DEGRADATION HAVE UNDERGONE THE ESTABLISHMENT OF COMPLAINT CODES SPECIFICALLY IDENTIFYING FOAM DEGRADATION, FOR THE TRILOGY SERIES. A FIELD CORRECTION ACTION (2021-05-A) WAS INITIATED, AND MEDICAL DEVICE RECALL LETTERS WERE ISSUED. A FIELD ACTION WAS INITIATED TO REPLACE PE-PUR FOAM IN AFFECTED PRODUCTS; DEGRADATION WAS ADDED TO THE RESPECTIVE DFMEAS AND THE RISK MANAGEMENT FILE¿ ER 2200179 V42(TRILOGY RISK MATRIX) WAS UPDATED TO INCLUDE HAZARDS ASSOCIATED WITH FOAM DEGRADATION BASED ON COMPLAINTS ANALYZED THROUGH VARIOUS HEALTH HAZARD EVALUATIONS (HHES). RISK TAGS ¿ ALLERGY01, TOXIC01 REFLECT THE SAFETY RISK ASSESSMENT OF DESIGN CONTAINING THE AFFECTED PE-PUR FOAM. THESE COMPLAINTS WERE MONITORED AND TRENDED IN ACCORDANCE WITH THE COMPLAINT TRENDING PROCEDURES. IF THE COMPLAINTS WERE DETERMINED TO MEET THE CRITERIA FOR ESCALATION, THEY WERE ESCALATED FOR RISK ASSESSMENT THROUGH THE POST MARKET CLINICAL ESCALATION PROCESS. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAVE LED TO UNACCEPTABLE LEVELS OF SEVERITY OR PROBABILITIES OF HARM, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. THE DEVICE MENTIONED IN THIS COMPLAINT HAS EXCEEDED ITS USEFUL LIFE PER THE APPLICABLE IFU. MULTIPLE SERVICE ACTIVITIES OCCUR DURING THE DEVICE¿S USEFUL LIFE ACCORDING TO THE DEVICE¿S SERVICE MANUAL. THESE SERVICE ACTIVITIES, IN ADDITION TO ANY PRIOR COMPLAINT INVESTIGATIONS, HAVE ALTERED THE DEVICE FROM ITS ORIGINAL STATE DURING MANUFACTURING. ANY ISSUE FOUND DURING MANUFACTURING THAT IS POTENTIALLY DOCUMENTED IN THE DHR FOR THIS DEVICE DOES NOT HAVE A CAUSAL RELATIONSHIP TO THE ALLEGATIONS OR ISSUES IN THIS COMPLAINT. THEREFORE, THE DHR FOR THIS DEVICE WILL NOT BE REVIEWED AT THIS TIME. HOWEVER, THE DHR FILES FOR THIS DEVICE ARE AVAILABLE AND CAN BE ACCESSED UPON SPECIFIC REQUEST.

    Description of Event or Problem · 0

    THE TRILOGY 100 VENTILATOR, U.S.A - BT DEVICE WAS EVALUATED 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 IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. NO REPAIR WAS PERFORMED. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16613 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1