MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1054097
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of cell undervoltage 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.
Event or Problem Description
A trilogy 100 ventilator device was returned to a third-party service center for service.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, the service technician observed cell undervoltage error code e210 (err_tda_cell_under_voltage_int_battery_log _only) in the error log.This error is generated from a battery cell under-voltage inside the battery pack.No documentation of a replaced component to address the issue.Additionally, one rubber foot, the passive porting block, and power cord clamp were missing.The maintenance label and pollen air filter need to be replaced for preventive maintenance.No parts will be replaced; the device will be scrapped as per customer request.

• 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 ; 7247330200
• MDR Report Key: 25669953
• Report Number: 2518422-2026-028051
• Device Sequence Number: 12172072
• Product Code: CBK
• UDI-Device Identifier: 00606959022751
• UDI-Public: (01)00606959022751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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
• Operator of Device: Other
• Device Model Number: 1054097
• Device Catalogue Number: 1054097
• Device Lot Number: 100519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2010
• 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