BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 25066797 · Received May 4, 2026

    Report

    Report Number
    2518422-2026-011495
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 4, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE OF 210 240 V-AC POWER SOURCE PEAK POWER IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION LOSS OF FUNCTION/LOSS OF PRIMARY 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 TRILOGY 100 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE FAILED THE 210 240 V-AC POWER SOURCE PEAK POWER TEST STEP DURING TESTING. THE TECHNICIAN REMOVED ALL POWER FROM THE UNIT, REAPPLIED POWER, THEN REBOOT /RE-TESTED THE DEVICE. NO PARTS WERE REPLACED IN REGARD TO THE FAILED TEST. THE DEVICE PASSED ALL FINAL TEST. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE ONLY REPLACED AS PART OF MAINTENANCE OF THE DEVICE OR DUE TO COSMETIC/PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THIS DEVICE BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287960 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 150414 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1