MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR, U.S.A.; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1054260
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	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy100 ventilator usa was returned to a third-party service center for service.There was no report of patient harm or injury associated with this event.The device was not reported to be in patient use at the time of service.During evaluation at the third-party service center, review of the device event log identified err_vpwrfail_oscilating_failure, indicating a u24 or u26 circuitry failure on the system board or cpu daughter board and loss of v power fail, as well as err_vpwrfail_failure related to the system pca-cpu daughter card v power fail circuit.The reported issue was confirmed during investigation.To address these conditions, the system board and central processing unit board assembly were replaced.In addition, several components were identified as physically damaged and/or missing and required replacement.These conditions were determined not to affect patient therapy.Following repair, the device successfully passed functional testing and met specification requirements.
Additional Manufacturer Narrative
The reported failure of system board and central processing unit board assembly 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.The device mentioned in this complaint has exceeded its useful life per the applicable ifu.

• Brand Name: TRILOGY100 VENTILATOR, U.S.A.
• 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: 25659126
• Report Number: 2518422-2026-027718
• Device Sequence Number: 16065440
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: (01)00606959015364
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 1054260
• Device Catalogue Number: 1054260
• Device Lot Number: 100329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2010
• 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