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

Model Number	1040007
Medical Device Problem Codes	Circuit Failure (1089); Contamination (1120); Failure to Calibrate (2440); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of oxygen blending module printed circuit assembly 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.
Event or Problem Description
The manufacturer received information alleging the positive and negative flow verify, and significant event log test steps had failed on a trilogy 202 device.The device was not in use on a patient at the time of the occurrence.During the evaluation it was noted that an error code, oxygen blending module (obm) accuracy urgent, was observed in the device's error log had caused the significant event log test case to fail on the device.The manufacturer's service technician evaluated and determined the obm printed circuit assembly (pca) had caused the error code to generate and the significant event log test case to fail on the device.The manufacturer's service technician found contamination on the flow assembly, blower, muffler, bellows, 200/202/o2 tubing, thermistor, porting block adapter and adapter cap, thermistor o-ring, and physical damage to the stirring fan retainer.In conclusion, the device's obm pca, flow assembly, blower, muffler, bellows, 200/202/o2 tubing, thermistor, porting block adapter and adapter cap, thermistor o-ring, and physical damage to the stirring fan retainer were replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the front enclosure, overlay, and porting block were replaced for physical damage unrelated to the reportable issue.The power cord, cord clamp, and threaded cap were replaced due to missing on the device.These were unrelate to the reportable issue.The device passed all final testing.

• Brand Name: TRILOGY
• 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: 25177706
• Report Number: 2518422-2026-013950
• Device Sequence Number: 10693288
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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
• Operator of Device: Other
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Device Lot Number: 140423
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2014
• 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