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

Model Number	1054655
Medical Device Problem Codes	Circuit Failure (1089); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 100 ventilator was returned to the manufacturer for service.There was no reported patient involvement.During the evaluation of the device at the manufacturer's service center a ventilator service required code was found related to a prox press railed.The service technician states that the sensor printed circuit assembly (pca) board that mounts the proximal pressure sensor was replaced.Additionally, the pollen filter was replaced.The original sensor pca was sent to the product investigation lab for further testing.Repair testing, battery check, valve check, run in testing, and cleaning were performed.The unit operated properly.
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy 100 ventilator was returned to the manufacturer for service.There was no reported patient involvement.During the evaluation of the device at the manufacturer's service center a ventilator service required code was found related to a prox press railed.The service technician states that the sensor printed circuit assembly (pca) board that mounts the proximal pressure sensor was replaced.Additionally, the pollen filter was replaced.The original sensor pca was sent to the product investigation lab for further testing.Repair testing, battery check, valve check, run in testing, and cleaning were performed.The unit operated properly.On the previous report the (root parent) other relevant event information section was incorrectly filled out with not-reportable language.The field should have been left blank.The field has since been updated.

• 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: 23774707
• Report Number: 2518422-2025-112545
• Device Sequence Number: 21365225
• Product Code: CBK
• UDI-Device Identifier: 00606959025387
• UDI-Public: (01)00606959025387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/11/2025

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: 1054655
• Device Catalogue Number: 1054655
• Device Lot Number: 130227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2013
• 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