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

Model Number	1040005
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	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of dp null valve test is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.The device mentioned in this complaint has exceeded its useful life per the applicable ifu.
Event or Problem Description
A trilogy 200 ventilator manufactured in the u.S.A.Was returned to a third-party service center for routine preventative maintenance.There was no allegation of patient harm, and the device was not reported to be in patient use at the time of return.During evaluation at the third-party service center, the device failed the dp null valve test step.Investigation identified the issue with the active exhalation control module (aecm), which was replaced to address the failure.Additionally, the missing rubber feet, enclosure seal kit, and handle o-ring were replaced.The label thtpol 44.5 x 50.8 mm wht was also replaced due to an obsolete revision.Following service, the device was inspected and tested and met all applicable acceptance criteria and customer requirements.

• Brand Name: TRILOGY 200 VENTILATOR, U.S.A.
• 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: 25326049
• Report Number: 2518422-2026-017340
• Device Sequence Number: 9675651
• Product Code: CBK
• UDI-Device Identifier: 00606959022737
• UDI-Public: (01)00606959022737
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 1040005
• Device Catalogue Number: 1040005
• Device Lot Number: 150424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2015
• 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