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

Model Number	U1040007
Medical Device Problem Codes	Computer Software Problem (1112); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilation service required error code was found 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was observed on the device's error log.The manufacturer's service technician further evaluated, and the software was outdated on the device.In conclusion, the device's software was upgraded to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the threaded cap was replaced for missing on the device, which is unrelated to the reported issue.The pollen filter was replaced for preventative maintenance unrelated 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: 24201561
• Report Number: 2518422-2026-003399
• Device Sequence Number: 12139458
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/28/2026

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: U1040007
• Device Catalogue Number: U1040007
• Device Lot Number: 170227
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2017
• 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