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

Model Number	CN1040000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy 202 ventilator was reported to have been evaluated by remote technical service and onsite technical service for an issue associated with a reported alarm.There was no harm or injury reported.Troubleshooting activities by philips remote service technician indicated the device was in use with a patient at the time the device alarm occurred.It was reported the alarm prompted for maintenance of the ventilator and the device was fully functional.The patient was switched to a different ventilator to continue with monitoring.Onsite service was provided by philips.Review of the device error code log revealed error code e-344 indicating an oxygen blending module (obm) accuracy issue.The device was returned to the factory for repair.Due to the obm error, the obm printed circuit board assembly was replaced.The system meets the specification for the performed service and is returned to use.Additional findings not related to the malfunction/issue: the blower motor was replaced.

• 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: 24637216
• Report Number: 2518422-2026-009743
• Device Sequence Number: 13222109
• Product Code: CBK
• UDI-Device Identifier: 00606959022812
• UDI-Public: (01)00606959022812
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: CN1040000
• Device Catalogue Number: CN1040000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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