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

Model Number	1032804
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device failed a test step during testing.The device's active exhalation control module was replaced to address the issue.In addition of the above evaluation, the device's following parts were replaced as regulated by maintenance procedure to prevent failure: pollen filter, exhaust fan assembly, 43-micron filter.The technician performed repair test, alarm check, battery check, run in tests, cleaning then confirmed the unit operated properly.The device's software version was checked.The device's the air path foam and the inlet air path assembly will be replaced when replacement air path foams and inlet air path assemblies arrive.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16810373
• Report Number: 2518422-2023-09707
• Device Sequence Number: 17650738
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Health Professional
• Device Model Number: 1032804
• Device Catalogue Number: 1032804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown