MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040007
Medical Device Problem Codes	Circuit Failure (1089); Leak/Splash (1354); Mechanical Problem (1384); Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the device failed at the dp calibration step due to pressure continuously falling.Replaced sensor board cable, device still failed testing.When checking inside device for faulty connections and found minor cosmetic damage to the replaced porting block adapter, so it was replaced again.Device still failed testing, so the tubing was replaced again.Device still failed testing.At this point used the individual step testing procedure to determine the cause of the failures, and found that the active exhalation module was likely not closing fully, so a new unit was installed again, however the device still failed testing, so the mainboard was replaced as well under the assumption that a faulty signal was preventing the exhalation module from closing properly.Device still failed testing.Further investigation found that the sensor board was likely defective, so it was replaced again, and the device passed the step that was previously failing, so the board has been set aside as defoa.Device then failed the oxygen blending module positive and negative flow steps, so the flow elements and tubing were replaced under suspicion of a leak.Additionally, the oxygen blending module manifold assembly diss connector was found to have a bent filter, so the manifold assembly was replaced as well.Additionally, incoming inspection per (b)(4) shows both damage and evidence of tobacco contamination to the handle and front, rear, and obm enclosures, as well as missing power cord, cord retainer, and threaded cap.Also recommend replacing porting block due to tobacco contamination.Ctq inspection shows damaged enclosure seal and contaminated base enclosure seal.While repairing the device, more contamination was found in/on the flow sensor assembly, 200/202/o2 tubing, active exhalation module, sensor board, thermistor and o-ring, porting block adapter and caps, low flow tubing, base enclosure, top plate enclosure, blower motor, keypad, whisper cap, and filter duct assembly.The device passed final test.

• Brand Name: TRILOGY 202
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 24130142
• Report Number: 2518422-2026-100179
• Device Sequence Number: 10344645
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• 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): 01/21/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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