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

Model Number	CA1032800
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the 120 vac power source peak power test step had failed on a trilogy 200 device.The device was not in use on a patient at the time of the occurrence.The trilogy 200 device was being evaluated by a third-party service center when the issue occurred on the device.During the evaluation, there is no documentation stated on a root cause and/or any component replacement to resolve the 120 vac power source peak power test step failing on the trilogy 200 device.In conclusion, the third-party service technician reset the device to address the issue.The root cause isn't confirmed at this time.Additionally, during the service of the device, the handle o-ring, rubber feet, and power cord clamp were replaced due to missing on the device.These were unrelated to the reported issue.The handle assembly and universal porting block were replaced for physical damage unrelated to the reportable issue.The device passed all final testing.
Additional Manufacturer Narrative
The bad was entered incorrectly from the previous report that was sent in.The bad has been added for a correction to the previous follow-up report.The bad was 04/01/2026.The manufacturer received information alleging the 120 vac power source peak power test step had failed on a trilogy 200 device.The device was not in use on a patient at the time of the occurrence.The trilogy 200 device was being evaluated by a third-party service center when the issue occurred on the device.During the evaluation, there is no documentation stated on a root cause and/or any component replacement to resolve the 120 vac power source peak power test step failing on the trilogy 200 device.In conclusion, the third-party service technician reset the device to address the issue.The root cause isn't confirmed at this time.Additionally, during the service of the device, the handle o-ring, rubber feet, and power cord clamp were replaced due to missing on the device.These were unrelated to the reported issue.The handle assembly and universal porting block were replaced for physical damage 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: 24809691
• Report Number: 2518422-2026-010518
• Device Sequence Number: 9620778
• Product Code: CBK
• UDI-Device Identifier: 00606959022782
• UDI-Public: (01)00606959022782
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093416
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: CA1032800
• Device Catalogue Number: CA1032800
• Device Lot Number: 140424
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2014
• 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