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

Model Number	1040000
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that a ventilator service required error code was found during preventative maintenance on a trilogy 202 device.The device was not in use on a patient at the time of the occurrence.The trilogy 202 device was being evaluated at a third-party service center service center when the reported issue occurred on the device.During the evaluation of the device, it had failed oxygen blending module (obm) calibration testing on this device.The third-party service technician found an error code, oxygen blending module (obm) accuracy urgent service, was observed on the device's error log.The third-party service technician further evaluated and determined the obm printed circuit assembly (pca) had caused the obm calibration testing to fail on the device.In conclusion, the device's obm pca was replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the third-party service technician heard a loud whistling vibration when producing the high pressures and alleged it sounded like a valve was not seated correctly on the device.The third-party service technician inspected the device and found no fault with the device.This was unrelated to the reported 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: 24549154
• Report Number: 2518422-2026-008639
• Device Sequence Number: 5662684
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 1040000
• Device Catalogue Number: 1040000
• Device Lot Number: 200117
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2020
• 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