MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO IBERIA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ES2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging assistance required.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the initial evaluation of the device at third-party service center, ventilator inoperative error codes were observed.Evt_tpy_held_in_bm means the therapy cpu is still running in boot monitor software.The system board needs to be replaced to address the issue.Evt_system_version_mismatch_ui means the ui software version string does not match the overall system version string.The display board needs to be replaced to address the issue.Additionally, during the initial evaluation of the device at third-party service center, non-ventilator inoperative error codes were observed.Evt_keypad_stuck means one of the physical keys is stuck, or there is an issue with the keypad.There was no report that device could not be powered on so therapy can be changed via touchscreen.Also, evt_audio_pause_key_stuck means the audio pause button on the keypad is stuck.The front panel / keypad needs to be replaced to address these issues.

• Brand Name: TRILOGY EVO IBERIA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24460542
• Report Number: 2518422-2026-006819
• Device Sequence Number: 10052012
• Product Code: CBK
• UDI-Device Identifier: 00606959054080
• UDI-Public: (01)00606959054080
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ES2110X15B
• Device Catalogue Number: ES2110X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown