MAUDE Adverse Event Report: Respironics, Inc. Trilogy 100; Ventilator, Continuous, Facility Use

Model Number	1054260B
Medical Device Problem Codes	Mechanical Problem (1384); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 100 ventilator device was returned to a service center for service for recertification.There is no allegation of serious or permanent harm or injury.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device, the device failed the active exhalation purge valve closed test step.The service technician replaced the aecm (active exhalation control module) to correct the issue.Additionally, the rubber feet, labels, front enclosure overlay, and cord retainer needed to be replaced.The device passed final testing.
Additional Manufacturer Narrative
The reported failure of active exhalation purge valve closed 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.

• Brand Name: Trilogy 100
• 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 ; +1(724)733-0200
• MDR Report Key: 50948175
• Report Number: 2518422-2026-046651
• Device Sequence Number: 21444256
• Product Code: CBK
• UDI-Device Identifier: 00606959026353
• UDI-Public: (01)00606959026353
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 1054260B
• Device Catalogue Number: 1054260B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2018
• 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