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

Model Number	1040005
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 200 ventilator was returned to the manufacturer's service center for completion device evaluation.There was no injury or harm reported.During run-in, the device alarmed for error code e-193 was noted in the error log causing a ventilator service required alarm and "internal battery depleted" alarms.Replacement of the internal battery is required to remedy this issue.Additional findings not related to the malfunction/issue: during evaluation, it was noted the sn/mn label and was replaced due to having the incorrect gtin/revision.The rubber feet were missing and required replacement.The cord retainer was missing and required replacement.The rear case seam gasket was damaged and required replacement.A "ventilator service required" for check circuit, low expiratory, high expiratory and internal battery depleted.Upon investigation, the transition tube was found to not be connected to the flow sensor which caused the "check circuit, low expiratory and high expiratory" alarms.The transition tube was re-connected and the device re-assembled to address this issue.
Additional Manufacturer Narrative
It was previously reported: a trilogy 200 ventilator was returned to the manufacturer's service center for completion device evaluation.There was no injury or harm reported.During run-in, the device alarmed for error code e-193 was noted in the error log causing a ventilator service required alarm and "internal battery depleted" alarms.Replacement of the internal battery is required to remedy this issue.Additional findings not related to the malfunction/issue: during evaluation, it was noted the sn/mn label and was replaced due to having the incorrect gtin/revision.The rubber feet were missing and required replacement.The cord retainer was missing and required replacement.The rear case seam gasket was damaged and required replacement.A "ventilator service required" for check circuit, low expiratory, high expiratory and internal battery depleted.Upon investigation, the transition tube was found to not be connected to the flow sensor which caused the "check circuit, low expiratory and high expiratory" alarms.The transition tube was re-connected, and the device re-assembled to address this issue.Additional information has been received related to the device repair: replacement of the internal battery pack was completed.The device then passed all testing and was determined to operate properly.

• Brand Name: TRILOGY
• 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: 23426102
• Report Number: 2518422-2025-111454
• Device Sequence Number: 18605457
• Product Code: CBK
• UDI-Device Identifier: 00606959022737
• UDI-Public: (01)00606959022737
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 1040005
• Device Catalogue Number: 1040005
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2014
• 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