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

Model Number	1040007
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the device failed a test step for dp purge valve, with the testing technician noting whistling heard from the device during the test.Investigation found no obvious leaks, so the recommendation is for the replacement of the porting block adapter and tubing.Customer declined repair upcharge; device to be returned unrepaired.Additionally, incoming inspection per pur5103123 shows device has no damaged components but is missing its rubber feet and threaded cap.Ctq inspection shows no issues.Device error logs show no urgent service alarms.

• Brand Name: TRILOGY 202
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 24085825
• Report Number: 2518422-2026-100145
• Device Sequence Number: 5878679
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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
• Operator of Device: Other
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2015
• 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