BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 22956894 · Received September 3, 2025

    Report

    Report Number
    2518422-2025-109614
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 8, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM A PHILIPS SERVICE TECHNICIAN THAT THE LOW FLOW OXYGEN (O2) TEST STEP HAD FAILED ON THE TRILOGY 100 DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE PHILIPS SERVICE TECHNICIAN EVALUATED AND DETERMINED THE INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING HAD CAUSED THE LOW FLOW O2 TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING TO ADDRESS THIS ISSUE ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN RE-PERFORMED THE TESTING ON THE DEVICE, AND ALL TESTING ON THE DEVICE HAD PASSED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS DAMAGE FOUND TO THE FRONT AND REAR ENCLOSURE CASES, AND HANDLE. THE PHILIPS SERVICE TECHNICIAN HAD REPLACED THE DEVICE'S FRONT AND REAR ENCLOSURE CASES, AND HANDLE TO ADDRESS THESE ISSUES. THE PHILIPS SERVICE TECHNICIAN WAS NOT ABLE TO CONFIRM THE GAP BETWEEN ENCLOSURES. THE PHILIPS SERVICE TECHNICIAN CLEANED THE OUTER ENCLOSURE ON THIS DEVICE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM A PHILIPS SERVICE TECHNICIAN THAT THE LOW FLOW OXYGEN (O2) TEST STEP HAD FAILED ON THE TRILOGY 100 DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE PHILIPS SERVICE TECHNICIAN EVALUATED AND DETERMINED THE INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING HAD CAUSED THE LOW FLOW O2 TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING TO ADDRESS THIS ISSUE ON THE DEVICE. THE MANUFACTURER'S EVALUATION IS STILL ONGOING DUE TO THE DEVICE NEEDS TO BE RETESTED AFTER THE PARTS HAD BEEN REPLACED ON THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS DAMAGE FOUND TO THE FRONT AND REAR ENCLOSURE CASES, AND HANDLE. THE PHILIPS SERVICE TECHNICIAN HAD REPLACED THE DEVICE'S FRONT AND REAR ENCLOSURE CASES, AND HANDLE TO ADDRESS THESE ISSUES. THE PHILIPS SERVICE TECHNICIAN WAS NOT ABLE TO CONFIRM THE GAP BETWEEN ENCLOSURES. THE PHILIPS SERVICE TECHNICIAN CLEANED THE OUTER ENCLOSURE ON THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386776 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown