MAUDE Adverse Event Report: Respironics, Inc. Trilogy Evo, Japan; Ventilator, Continuous, Facility Use

Model Number	RJP2110X16B
Medical Device Problem Codes	Output Problem (3005); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that on 02sep2026 a visiting nurse reported that the trilogy evo ventilator¿s alarm silence button/touch panel was unresponsive.The representative guided the patient¿s mother through a forced shutdown and restart, but the touch panel remained unresponsive, preventing ventilation from being started.The mother was instructed to use an ambu bag and call emergency services if the patient¿s condition worsened.The representative visited the home and replaced the device with another unit of the same model, but its touch panel was also unresponsive.A visiting nurse subsequently assessed the patient, checked the device settings and alarms, and measured vital signs.No patient harm or ongoing equipment issues were identified, and the representative left the home.The device was returned to a service center for evaluation.The evaluation found that the reported issue was not duplicated by operational checking.The event log showed repeated e192 (sound silence button pressed) events, but e190 (sound silencing executed) was not recorded, indicating that the sound was not silenced and the issue was attributed to a software failure.The touch panel not responding issue was not confirmed by operational checking, and no related abnormality was observed in the device or event log.The display was replaced to prevent recurrence, the software was upgraded from 1.06.10.00 to 1.06.15.00, and final test, battery check, valve check, run-in tests, and cleaning confirmed that the unit operated properly.
Additional Manufacturer Narrative
The reported 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.Dhr review was performed for the complaint device (b)(6).Review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: Trilogy Evo, 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 ; +1(724)733-0200
• MDR Report Key: 50930115
• Report Number: 2518422-2026-046544
• Device Sequence Number: 18518821
• Product Code: CBK
• UDI-Device Identifier: 00606959051973
• UDI-Public: (01)00606959051973
• 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: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: RJP2110X16B
• Device Catalogue Number: RJP2110X16B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown