BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY

    MDR report key: 22981965 · Received September 5, 2025

    Report

    Report Number
    2518422-2025-109758
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 LOW FLOW O2 TEST STEP, BUT IT FAILED AGAIN ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN RE-EVALUATED THE DEVICE AND FOUND THE GREY REMOVABLE FOAM HAD CAUSED THE LOW FLOW O2 TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN READJUSTED THE GREY REMOVABLE FOAM TO ADDRESS THIS ISSUE. AFTERWARDS, THE PHILIPS SERVICE TECHNICIAN RE-PERFORMED THE TEST ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN CONFIRMED THE DEVICE HAD PASSED ALL TESTING ON IT. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS THE RUBBER FEET MISSING AND DAMAGE TO THE CORD RETAINER. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S ENCLOSURE RUBBER FEET AND CABLE CLAMP TO ADDRESS THESE TWO ISSUES.

    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 THE RUBBER FEET MISSING AND DAMAGE TO THE CORD RETAINER. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S ENCLOSURE RUBBER FEET AND CABLE CLAMP TO ADDRESS THESE TWO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976898 TRILOGY VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown