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

Model Number	DE2110X13B
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	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported vent service required error indicating a failure of the touchscreen display 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.
Event or Problem Description
The manufacturer received a report that a trilogy evo ventilator was returned for service for the unit to be checked.There were no reports of patient harm or injury associated with this event.The device was returned to a third-party service center for evaluation.The device log files were successfully downloaded and reviewed.During the 'in process" evaluation, a ¿vent service required¿ alarm was identified, indicating a failure of the touchscreen display.The display printed circuit assembly (pca) requires replacement to address this issue.In addition, the front panel keypad button was damaged, the keypad does not function properly, and the front panel needs to be replaced.The internal battery door was found to be damaged and requires replacement.Furthermore, the blower assembly, machine flow sensor, tubing fio2, and tubing-blower chassis were observed to be contaminated with dust and dirt.As part of four-year preventive maintenance, the air foam inlet filter, muffler, and particulate filter need to be replaced.A preventive maintenance (pm) label will be added to the unit.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, a follow up/supplemental report will be completed.

• 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 ; 7247330200
• MDR Report Key: 24852119
• Report Number: 2518422-2026-010685
• Device Sequence Number: 5651864
• Product Code: CBK
• UDI-Device Identifier: 00606959054110
• UDI-Public: (01)00606959054110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: DE2110X13B
• Device Catalogue Number: DE2110X13B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown