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

Model Number	EU2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of therapy cpu is still running in boot monitor software 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 serial number, (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
The manufacturer received information alleging actionable errors occurred on a trilogy evo ventilator following completion of a software upgrade.No patient harm or injury was reported.The device was not in patient use at the time of the event.After successful completion of the software update, device error logs were reviewed by a third-party service technician.The review identified an evt_tpy_held_in_bm ¿ventilator inoperative¿ alarm indicating the therapy central processing unit (cpu) is still running in boot monitor software.Replacement of the device¿s system printed circuit assembly (pca) was determined to be necessary to correct this issue.Additionally, an evt_internal_batt_failed error was identified in the event log, indicating the internal lithium-ion battery is reporting a permanent failure.Replacement of the internal battery was determined to be necessary.Unrelated to the reported malfunction, the detachable lithium-ion battery also requires replacement due to an evt_detach_batt_failed error, indicating a permanent failure condition.A final report is being submitted.If additional information is received, a supplemental report will be filed.

• Brand Name: TRILOGY EVO, EU
• 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: 25325760
• Report Number: 2518422-2026-017339
• Device Sequence Number: 5291645
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown