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

Model Number	IT1054096B
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The capa process identified complaints not being created for quality issues found during third party servicing.Based on a review of records impacted by the identified issue, it was determined that this record needed to be corrected and is now being submitted accordingly.
Event or Problem Description
A device was returned to a service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of patient harm or injury.A trilogy 100 ventilator was returned to a third-party service center for foam remediation on the device.There was no harm or injury reported.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation.The device failed functional testing relating to the positive flow verification test step.The software was upgraded to address the issue.Additionally, the device failed a not-reportable test step relating to a damaged lcd display.There is no documentation stated on a root cause or a component replacement.Additionally, a not-reportable internal battery depleted, and check circuit error code were found in the device's error log.The service technician states that the internal battery was charged and the tubing was reconnected to resolve the issues.Run-in testing was performed again and the device passed.The customer requested the return of the device unserviced, therefore no repairs were performed.

• Brand Name: TRILOGY 100 VENTILATOR, ITALY - BT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 25044524
• Report Number: 2518422-2026-112783
• Device Sequence Number: 21243359
• Product Code: CBK
• UDI-Device Identifier: 00606959042933
• UDI-Public: (01)00606959042933
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: IT1054096B
• Device Catalogue Number: IT1054096B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2018
• 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