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

Model Number	EU2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilation service required error code was found during maintenance on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was returned to the third-party service center for maintenance.During the evaluation it was noted that an error code, battery not charging (e-059), was observed on the device's error log.The third-party service technician further evaluated and determined the detachable battery had cause the error code to occur on the device.In conclusion, the device's detachable battery needs replaced to address the issue.The root cause is confirmed at this time.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 supplemental report will be completed.Additionally, during the service of the device, the third-party service technician observed two additional error codes, ac disconnected (e-042) and internal battery in use (e-045), in the device's error log.The third-party service technician evaluated but did not provide any information on the cause for these two error codes, which were unrelated to the reportable issue.The muffler, air foam filter, and particulate filter needs replace for preventative maintenance unrelated to the reportable issue.
Additional Manufacturer Narrative
The company previously reported the incorrect bad (01/22/2026) that was filed.The correct bad is 02/06/2026.The manufacturer received information alleging a ventilation service required error code was found during maintenance on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was returned to the third-party service center for maintenance.During the evaluation it was noted that an error code, battery not charging (e-059), was observed on the device's error log.The third-party service technician further evaluated and determined the detachable battery had cause the error code to occur on the device.In conclusion, the device's detachable battery needs replaced to address the issue.The root cause is confirmed at this time.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 supplemental report will be completed.Additionally, during the service of the device, the third-party service technician observed two additional error codes, ac disconnected (e-042) and internal battery in use (e-045), in the device's error log.The third-party service technician evaluated but did not provide any information on the cause for these two error codes, which were unrelated to the reportable issue.The muffler, air foam filter, and particulate filter needs replace for preventative maintenance unrelated to the reportable issue.

• Brand Name: TRILOGY
• 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: 24308003
• Report Number: 2518422-2026-004627
• Device Sequence Number: 17428767
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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