MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE.

Model Number	R1032804TP
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center a code indicating circuit disconnect alarm had occurred frequently was found in the ventilator's downloaded error log.Since it was considered that a temporal failure had been occurring in the sensor, sensor pca was replaced to prevent recurrence.Additionally, the item for testing the exhalation valve of functional test confirmed that the open/close movement of the valve was slow.Therefore, active exhalation control module was replaced to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported, a ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center a code indicating circuit disconnect alarm had occurred frequently was found in the ventilator's downloaded error log.Since it was considered that a temporal failure had been occurring in the sensor, sensor pca was replaced to prevent recurrence.Additionally, the item for testing the exhalation valve of functional test confirmed that the open/close movement of the valve was slow.Therefore, active exhalation control module was replaced to address the issue.The replaced components were returned to the product investigation laboratory, and it has been determined that no operational issues were found, and the root cause of the failure could not be determined from service.The sensor (pca) board and the active exhalation control module operates as designed.

• Brand Name: TRILOGY 200
• 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: 18571199
• Report Number: 2518422-2024-04080
• Device Sequence Number: 18265625
• Product Code: CBK
• UDI-Device Identifier: 00606959025370
• UDI-Public: 00606959025370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093416
• 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

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: R1032804TP
• Device Catalogue Number: R1032804TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2017
• 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