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

Model Number	KR2110X15B
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	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo, korea device was returned to a third-party service center for evaluation due to a service required alarm.There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation of the device, the service technician confirmed that error evt_tpy_held_in_bm (error code 156) was found in the device error code log, and the system printed circuit assembly (pca) was replaced to address this error code.Additionally, the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.The in-line filter prox was also replaced due to dust contamination.Due to 4-year pm assessment, the muffler assembly and air inlet foam filter were replaced.After the evaluation and rework were complete, the device passed final testing.
Additional Manufacturer Narrative
The reported failure of evt_tpy_held_in_bm is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary 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 sn.Review confirms that the device met the final acceptance criteria and was released for final distribution.Device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined.At this time, the reported error code event date is based solely on the third-party service center's device evaluation.

• Brand Name: Trilogy Evo
• 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: 50897197
• Report Number: 2518422-2026-046458
• Device Sequence Number: 14910245
• Product Code: CBK
• UDI-Device Identifier: 00606959055483
• UDI-Public: (01)00606959055483
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: KR2110X15B
• Device Catalogue Number: KR2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2021
• 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