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

Model Number	ES2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report that a trilogy evo ventilator was returned for service.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 "in process" evaluation, analysis identified a ¿vent inop¿ condition associated with machine flow sensor drift exceeding specification (>0.2lpm).Replacement of the machine flow sensor was determined to be necessary to address this condition.Additionally, multiple event errors were identified that were unrelated to the reported malfunction.These events indicated that the motor controller entered a shutdown state due to a motor-related error, and the motor flux measurement is either too high or too low when the motor is in the run state.Replacement of the blower assembly was identified as the appropriate corrective action for these findings.An additional event indicated that a sensor offset during drift calculation exceeded allowable limits; replacement of the system printed circuit assembly (pca) was determined to be required.Inspection also identified contamination of the tubing fio2 and blower bellow seals with dirt.Due to the four-year preventive maintenance, the air foam inlet filter, muffler, and particulate filter will be replaced.The preventive maintenance 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.
Additional Manufacturer Narrative
The reported failure of "vent inop" condition associated with machine flow sensor drift exceeding specification (>0.2lpm) 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.

• 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: 24886711
• Report Number: 2518422-2026-010901
• Device Sequence Number: 21294991
• Product Code: CBK
• UDI-Device Identifier: 00606959054080
• UDI-Public: (01)00606959054080
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/15/2026

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: ES2110X15B
• Device Catalogue Number: ES2110X15B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2022
• 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