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

Model Number	R1054655B
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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report indicating that during a test run conducted in the sales office, a trilogy 100 ventilator displayed a low leak value, resulting in activation of a "low circuit leak" alarm.No harm or injury was reported in association with this event.The device was returned to the manufacturer¿s service center for evaluation.During operational testing, the "low circuit leak" alarm was successfully reproduced.Investigation determined that the alarm condition was caused by a malfunction of the flow sensor.To correct the issue, the flow sensor printed circuit assembly (pca) was replaced.Following the repair, the service technician performed functional verification testing, including a repair test, alarm check, battery check, run-in testing, and cleaning.The device was confirmed to be operating properly.

• 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: 24331464
• Report Number: 2518422-2026-004905
• Device Sequence Number: 13197795
• Product Code: CBK
• UDI-Device Identifier: 00606959052345
• UDI-Public: (01)00606959052345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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: R1054655B
• Device Catalogue Number: R1054655B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown