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

Model Number	CA1040000
Medical Device Problem Codes	Circuit Failure (1089); Computer Software Problem (1112); Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third-party service center for evaluation after previous repair.There was no harm or injury reported.This device was returned previously in april 2025 for the same issue and the oxygen blending module was replaced at that time.During the evaluation, service required alarm conditions indicating a failure of the oxygen blending module and a failure to communicate with the oxygen blending module were observed again.The device's oxygen blending module needs to be replaced to address the issue.Additionally, not related to the reportable issue, the device's rubber feet were missing and need replaced.The device's pollen filter and preventive maintenance label will be replaced per preventive maintenance protocol.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator was returned to a third-party service center for evaluation after previous repair.There was no harm or injury reported.This device was returned previously in april 2025 for the same issue and the oxygen blending module was replaced at that time.During the evaluation, service required alarm conditions indicating a failure of the oxygen blending module and a failure to communicate with the oxygen blending module were observed again.The device's oxygen blending module needs to be replaced to address the issue.During final testing the device failed a control pressure, monitor pressure and pproximal pressure verification test steps.The device was recalibrated to address the issues.The device's oxygen blending module was replaced per previous issue.The device was tested and 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: 24324065
• Report Number: 2518422-2026-004833
• Device Sequence Number: 21213165
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: CA1040000
• Device Catalogue Number: CA1040000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2016
• 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