MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200 VENTILATOR, U.S.A. - BT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040005B
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 200 ventilator, u.S.A.- bt was returned to the manufacturer for recertification.There was no allegation of patient harm.The device was not reported to be in patient use.The trilogy 200 device failed the leak test step during evaluation at the manufacturer¿s service center.The root cause was determined to be a hole in the tubing.The device¿s tubing was replaced to address the test failure.After the repair the device passed all testing.

• Brand Name: TRILOGY 200 VENTILATOR, U.S.A. - BT
• 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: 24677205
• Report Number: 2518422-2026-009965
• Device Sequence Number: 18724866
• Product Code: CBK
• UDI-Device Identifier: 00606959026445
• UDI-Public: (01)00606959026445
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 1040005B
• Device Catalogue Number: 1040005B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2014
• 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