MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	U1054260
Medical Device Problem Codes	Circuit Failure (1089); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 100 ventilator was returned to the manufacturer for service.There was no serious patient harm or injury that occurred or was reported.During evaluation of the device at the manufacturer, the device failed a test step relating to the primary and secondary audible alarms.The service technician states that during the evaluation, the unit powered on and the speakers noticeably did not work, confirming the test failure.The service technician tried replacing the speaker kit and reassembled the device and the speakers still did not work.It was determined that the front panel printed circuit assembly (pca) board was faulty and needs to be replaced to resolve the issue.Additionally, the base enclosure is cracked and needs to be replaced.The front case enclosure has physical damage and needs to be replaced.The device failed an o2 low flow test due to a misaligned gray removeable foam during evaluation.The foam was readjusted and passed testing.Additionally, the seam gasket, rubber feet, front and rear enclosure, enclosure gap, and handle need to be replaced.A repair quote was sent to the customer and is awaiting approval in order to proceed with the repair.

• Brand Name: TRILOGY 100
• 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: 23941016
• Report Number: 2518422-2026-000028
• Device Sequence Number: 13442900
• Product Code: CBK
• UDI-Device Identifier: 00606959026315
• UDI-Public: (01)00606959026315
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: U1054260
• Device Catalogue Number: U1054260
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2009
• 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