MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO, O2, EU; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	EU2100X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging "water has entered type o2 (white connection) of a trilogy evo, o2, eu device.There was no harm or injury reported.The device was not reported to be in patient use.During the "inprocess" evaluation of the trilogy evo, o2, eu device at third-party service center, it was documented that due to evt_o2_prop_stuck and evt_o2_regulation errors it appears that the oxygen blending module is defective and will need to be replaced.Additionally, not related while testing the device evt_voltage_3vs3_fail and evt_voltage_5vs2_fail error codes appeared, which indicate that the system board is defective and needs to be replaced.The device's blower, blower chassis plate, low-flow tube, bellow, system board tubing, machine flow sensor, fio2 tubing, and blower chassis plate tubing will need to be replaced due to contamination of water.Per the requirements of the four-year maintenance the device's air foam inlet filter, particulate filter internal and detachable battery will be replaced.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: TRILOGY EVO, O2, EU
• 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: 24626402
• Report Number: 2518422-2026-009711
• Device Sequence Number: 9068094
• Product Code: CBK
• UDI-Device Identifier: 00606959055674
• UDI-Public: (01)00606959055674
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/18/2026

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: EU2100X15B
• Device Catalogue Number: EU2100X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown