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

Model Number	LA1054096
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy 100 ventilator was returned to a third-party service center for evaluation.There was no patient involvement, and no harm or injury reported.The device was returned in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.On device evaluation, it was reported the device did not power on for a full evaluation and no device information was accessible.There was no evidence of foam degradation in the device.The device was scrapped without further evaluation or repair.
Additional Manufacturer Narrative
Device exceeds expected life.Dhr not required.The reported failure of the trilogy ventilator to power on 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.

• 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: 50915470
• Report Number: 2518422-2026-046516
• Device Sequence Number: 5369768
• Product Code: CBK
• UDI-Device Identifier: 00606959022836
• UDI-Public: (01)00606959022836
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: LA1054096
• Device Catalogue Number: LA1054096
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2010
• 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