BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2 VENTILATOR

    MDR report key: 18167206 · Received November 19, 2023

    Report

    Report Number
    2518422-2023-31013
    Event Type
    Malfunction
    Date Received
    November 19, 2023
    Date of Event
    October 19, 2023
    Report Date
    July 29, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K111610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVED INFORMATION ALLEGING THAT A "VENTILATOR SERVICE REQUIRED" ERROR CODE OCCURRED AND THAT THE POWER BUTTON FAILED TO RESPOND PROPERLY. THIS WAS FOUND IN THE SALES OFF BEFORE DELIVERY. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S OXYGEN BLENDER BOARD AND INTERFACE BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUE. DURING THE EVALUATION, IT WAS OBSERVED THAT ALL BUTTONS DID NOT RESPOND EVEN PRESSING THEM STRONGLY DURING AN OPERATIONAL CHECK, SO THE FRONT PANEL/KYE PAD LED PCA NEEDS TO BE REPLACED. THIS DEVICE WILL BE DISCARDED WITHOUT REPAIR DUE TO EARLY LEASE-UP.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A "VENTILATOR SERVICE REQUIRED" ERROR CODE OCCURRED AND THAT THE POWER BUTTON FAILED TO RESPOND PROPERLY. THIS WAS FOUND IN THE SALES OFF BEFORE DELIVERY. THE DEVICE WAS NOT IN PATIENT USE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744642 TRILOGY O2 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. R1040004TP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown