MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE.

Model Number	R1054655TP
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a check circuit alarm occurred.There was no harm or injury reported.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed in the device's event log.Since a temporal failure in active exhalation control module was considered as the cause of the occurrence, the active exhalation control module was replaced.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a check circuit alarm occurred.There was no harm or injury reported.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed in the device's event log.Since a temporal failure in active exhalation control module was considered as the cause of the occurrence, the active exhalation control module was replaced.The active exhalation control module was evaluated by the manufacturer's product investigation laboratory (pil) and found the active exhalation control module functioned as designed and operated without issue or error codes.

• Brand Name: TRILOGY 100
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE.
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19522214
• Report Number: 2518422-2024-36203
• Device Sequence Number: 8540414
• Product Code: CBK
• UDI-Device Identifier: 00606959033894
• UDI-Public: 00606959033894
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: R1054655TP
• Device Catalogue Number: R1054655TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2018
• 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