MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	CN1040000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a black screen occurred on a trilogy 202 ventilator.The device was not reported to be in use on a patient at the time of the occurrence.There was no allegation of harm or injury.Trilogy 202 ventilator has not yet been returned to the manufacturer.Good faith effort attempts are being made to gather additional information.If any additional information is received, a follow-up report will be filed.New information/ evaluation: the trilogy202 ventilator was evaluated by a remote service engineer, and it was determined that during system bootup/pc bootup/tsm bootup the first occurrence of black screen was with no accessories used.In conclusion the device was full functionality.Box h coding was updated.
Event or Problem Description
The manufacturer received information alleging a black screen occurred on a trilogy 202 ventilator.The device was not reported to be in use on a patient at the time of the occurrence.There was no allegation of harm or injury.Trilogy 202 ventilator has not yet been returned to the manufacturer.Good faith effort attempts are being made to gather additional information.If any additional information is received, a follow-up report will be filed.

• Brand Name: TRILOGY 202
• 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: 24177656
• Report Number: 2518422-2026-003239
• Device Sequence Number: 9557327
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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
• Device Lot Number: 190307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2019
• 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