BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 22171423 · Received June 9, 2025

    Report

    Report Number
    2518422-2025-106491
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 30, 2025
    Report Date
    January 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED BY THE MANUFACTURER: A TRILOGY EV300 VENTILATOR WAS RETURNED TOA THIRD PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, UPON INITIAL INSPECTION OF DEVICE, DEVICE FAILED ACTIVE EXHALATION VERIFICATION. THE REPAIRS HAVE NOT YET BEEN STARTED AND WILL BE HANDLED BY A PHILIPS AUTHORIZED SERVICE PROVIDER. THE TECHNICIAN IS WORKING TO SCHEDULE AN ONSITE VISIT ONCE THE DEVICE BECOMES AVAILABLE. FSES ARE ONSITE WORKING AND WILL DISPATCH ONCE THE DEVICE IS GIVEN TO THEM. PWO IS STILL PENDING ENTITLEMENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. NEW INFORMATION: A TRILOGY EV300 VENTILATOR WAS RETURNED TOA THIRD PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, UPON INITIAL INSPECTION OF DEVICE, DEVICE FAILED ACTIVE EXHALATION VERIFICATION. IN CONCLUSION THE 3 WAY SOLENOID VALVE AND PROPORTIONAL VALVE WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETESTED AND PASSED ALL TEST AND WAS RETURNED TO USE. ADDITIONALLY, THE 3 WAY SOLENOID VALVE AND PROPORTIONAL VALVE WERE SENT TO THE RIQL FOR THE ALLEGATION OF A AECM FAILED TEST STEP. THIS FAILURE IS BEING INVESTIGATED. NO FURTHER EVALUATION OF THIS PART IS REQUIRED AT THIS TIME. BOX H CODING WAS UPDATED.

    Description of Event or Problem · 0

    A TRILOGY EV300 VENTILATOR WAS RETURNED TOA THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, UPON INITIAL INSPECTION OF DEVICE, DEVICE FAILED ACTIVE EXHALATION VERIFICATION. THE REPAIRS HAVE NOT YET BEEN STARTED AND WILL BE HANDLED BY A PHILIPS AUTHORIZED SERVICE PROVIDER. THE TECHNICIAN IS WORKING TO SCHEDULE AN ONSITE VISIT ONCE THE DEVICE BECOMES AVAILABLE. FSES ARE ONSITE WORKING AND WILL DISPATCH ONCE THE DEVICE IS GIVEN TO THEM. PWO IS STILL PENDING ENTITLEMENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334162 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown