MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY O2 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	R1040004TP
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	04/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report that a trilogy o2 ventilator was replaced due to occurrence of a "ventilator service required" alarm.There were no reports or allegations of patient harm or injury.The device was returned to the manufacturer for evaluation.During an initial operational check, a ¿ventilator service required¿ alarm was not duplicated.Device log files were successfully retrieved and reviewed in their entirety.Review of the logs confirmed the presence of a ¿ventilator service required¿ alarm associated with error code err_obm_air_flow_sensor_failed, indicating a failure related to the air-side flow sensor within the oxygen blender module.To address the identified condition, the oxygen blender printed circuit assembly (pca), which includes the flow sensor, was replaced.In addition, the trilogy o2 pm1 preventive maintenance kit was replaced as part of schedule maintenance activities.Following corrective actions, the engineer performed post-repair verification testing, including alarm testing, battery performance checks, functional run-in testing, and device cleaning.The ventilator passed all evaluations and was confirmed to be operating within specifications.
Additional Manufacturer Narrative
The reported failure of a ventilator service required alarm associated with a failure related to the air-side flow sensor within the oxygen blender module 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.

• Brand Name: TRILOGY O2 VENTILATOR
• 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: 25044148
• Report Number: 2518422-2026-011384
• Device Sequence Number: 9580520
• Product Code: CBK
• UDI-Device Identifier: 00606959025394
• UDI-Public: (01)00606959025394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: R1040004TP
• Device Catalogue Number: R1040004TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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