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

Model Number	JP2100X16B
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging ("oxygen regulation" alarm and "ventilator service required" alarm occurred when they switched to low pressure oxygen) regarding a trilogy evo, o2 ventilator.The device was in use on a patient at the time of the occurrence.There was no report of patient harm or injury.The trilogy evo, o2 ventilator was returned to the manufacturer service center for evaluation, and the customer¿s complaint of "oxygen regulation" alarm occurred was reproduced.During the evaluation error codes in relation to o2_prop_stuck and obm_valve_failure were recorded in the device event log.It is determined that the issue was caused by a malfunction of the proportional valve inside oxygen blender module (obm) sub assembly, therefore the obm sub assembly was replaced to address the issue.Additionally, periodic maintenance 1 was performed and the air inlet foam filter and particle filter were replaced.The technician performed final test, battery check, valve check, run in tests and cleaning then confirmed the unit operated properly.The software version was upgraded from 1.06.10.00 to 1.06.15.00.
Additional Manufacturer Narrative
The reported failure of o2_prop_stuck and obm_valve_failure is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of 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.

• Brand Name: TRILOGY EVO, O2, JAPAN
• 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: 24938301
• Report Number: 2518422-2026-011060
• Device Sequence Number: 10728010
• Product Code: CBK
• UDI-Device Identifier: 00606959055582
• UDI-Public: (01)00606959055582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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
• Operator of Device: Other
• Device Model Number: JP2100X16B
• Device Catalogue Number: JP2100X16B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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