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

Model Number	1054260
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy 100 ventilator was returned for service.There was no serious patient harm or injury that occurred or was reported.The device was evaluated at a third-party service center.Initial inspection identified multiple issues, including missing rubber feet and a missing handle o-ring kit.In addition, the exhalation port block, handle kit, base enclosure kit, rear enclosure assembly, and front case were found to be cracked.The enclosure seal kit needed to be replaced due to a change in the rear enclosure and the warning label dom kit required replacement due to a change in the base enclosure.Additionally, the thtpol label required replacement due to unacceptable revision.During functional testing, the device failed the internal battery capacity test.This test verifies that the battery is charged to a particular level required for testing and does not impact therapy delivery.Review of the error logs following repair test identified a "vent service required" alarm associated with an internal li-ion battery permanent failure.An additional error indicating a battery cell under-voltage condition within the battery pack was also observed.The internal battery pack required replacement due to a functional failure.Following the repair, the device passed all testing.
Additional Manufacturer Narrative
The reported failure of vent service required alarm associated with an internal li-ion battery permanent failure 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.Therefore, the dhr for this device will not be reviewed at this time.

• 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: 25668568
• Report Number: 2518422-2026-028263
• Device Sequence Number: 10452645
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2015
• 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