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

Model Number	1054260
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 100 ventilator, u.S.A.Device was returned to the manufacturer for evaluation with no initial alleged complaint.During the evaluation at the manufacturer's product investigation laboratory (pil), the service technician confirmed that a thermal event occurred but could not determine the cause of the thermal event.Additionally, the device sn/mn label had to be added since the original had the incorrect gtin/revision.The device is being forwarded back to the customer via service.A final report is being filed, if additional information is received that changes the outcome of the investigation and associated coding, a supplemental report will be filed.
Additional Manufacturer Narrative
The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.Complaints for this failure were reviewed to assess for the observed probability levels and compare 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: 50239311
• Report Number: 2518422-2026-043178
• Device Sequence Number: 10296894
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: (01)00606959015364
• 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): 08/13/2026

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: 1054260
• Device Catalogue Number: 1054260
• Device Lot Number: 150415
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2015
• 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