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

Model Number	FR2110X14B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of ventilator service required alarm associated with failure of the internal battery system and a failure indicating that vbus dropped below 8.000v 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.
Event or Problem Description
The manufacturer received a report that a trilogy evo ventilator was returned for preventive maintenance.No patient injury or serious harm was reported.The ventilator was evaluated at a third-party service center.The device log files were successfully downloaded and reviewed in full.A ¿ventilator service required¿ alarm was identified, associated with failure of the internal battery system.This condition may result from the battery not being detected, a failure of the system printed circuit assembly (pca) as indicated by terminal voltage, wake voltage, or smbus communication errors, or an internal battery failure.The logs also identified an error indicating that vbus dropped below 8.000v.This condition may be associated with depletion of all available power sources, a fault in the active power source, or a power path circuit malfunction.Available service documentation did not indicate that any component replacements were required to resolve the reported issue.No additional actionable error codes were identified.Additionally, unrelated to the reported malfunction, the inline filter was found to be contaminated with dust.As part of preventive maintenance, the air foam inlet filter and particulate filter required replacement.The customer complaint was confirmed.Following preventive maintenance activities, the device passed all functional testing.A final report is being submitted.If any additional information is received, a supplemental report will be filed.

• 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: 25095917
• Report Number: 2518422-2026-011809
• Device Sequence Number: 5031632
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: (01)00606959055506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/06/2026

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: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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