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

Model Number	1040005B
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	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy 100 ventilator device was returned to a service center for service.There is no allegation of serious or permanent harm or injury.During the evaluation, the service technician observed an r ventilator inoperative error code e009 (err_dsp_motor_failure) in the error log.The blower will be replaced to address the error code.In addition, the cord retainer was missing and replaced, the keypad, front case, rear case, base enclosure with labels and feet, handle, and enclosure top plate have all been replaced for physical damage.The porting block adapter kit had a broken screw boss mount and was replaced, the interface pca was replaced due to a communication failure, and the exhaust fan and tubing kit were replaced due to contamination.The device passed all testing.
Additional Manufacturer Narrative
The reported failure of vent inoperability is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary 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.

• Brand Name: TRILOGY 200
• 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: 25233006
• Report Number: 2518422-2026-015037
• Device Sequence Number: 5017608
• Product Code: CBK
• UDI-Device Identifier: 00606959026445
• UDI-Public: (01)00606959026445
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 1040005B
• Device Catalogue Number: 1040005B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2015
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown