MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	CN1040000
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a failed test step occurred on atrilogy202 ventilator.The device was not reported to be in use on a patient at the time of the occurrence.The root cause isn't confirmed at this time.Good faith effort attempts will be made to gather additional information.If any additional information is received, a follow-up report will be filed.

• Brand Name: TRILOGY 202
• 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: 24647391
• Report Number: 2518422-2026-009807
• Device Sequence Number: 9894824
• Product Code: CBK
• UDI-Device Identifier: 00606959022812
• UDI-Public: (01)00606959022812
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: CN1040000
• Device Catalogue Number: CN1040000
• Device Lot Number: 180124
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2018
• 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