MAUDE Adverse Event Report: Respironics, Inc. Trilogy 100 Ventilator, U.S.A - BT; Ventilator, Continuous, Facility Use

Model Number	1054260B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
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
A trilogy100 ventilator, u.S.A., was returned to a third-party service center for routine preventive maintenance.There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation at the third-party service center, an error code 195- err_batt_low_state_of_health_int_li_ion was observed, indicating that the internal battery failed to charge.The evaluation did not identify a specific component malfunction requiring replacement to restore device functionality.The device logs were not available; therefore, the date of occurrence of the most recent error code could not be determined.At this time, the reported error code event date is based solely on information received from the customer and has not been confirmed through device evaluation.No root cause was established.No repair was performed, and the device was marked as scrap.Additionally, the device had a non-actionable error code 290- ventilator service required and visual inspection found no evidence of foam degradation, and no foam particles were observed during the evaluation.
Additional Manufacturer Narrative
The reported failure of the error code 195 - err_batt_low_state_of_health_int_li_ion internal li-ion battery 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 100 Ventilator, U.S.A - BT
• 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: 50900167
• Report Number: 2518422-2026-046487
• Device Sequence Number: 12262267
• Product Code: CBK
• UDI-Device Identifier: 00606959026353
• UDI-Public: (01)00606959026353
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• 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: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown