MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; PORTABLE ELECTRIC VENTILATOR

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	03/21/2024
Type of Reportable Event	Malfunction
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, there were no foam particles found in the device.The device failed functional testing relating to positive flow verification.The software was upgraded to address the issue.The service technician states that the device also failed the following not-reportable repair test steps: new porting block, sd card to ship, time out event log error, debug log, and reset operational hours.The device passed final testing.

• Brand Name: TRILOGY 100
• Common Device Name: PORTABLE ELECTRIC VENTILATOR
• 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: 25045580
• Report Number: 2518422-2026-112788
• Device Sequence Number: 9643105
• Product Code: CBK
• UDI-Device Identifier: 00606959042933
• UDI-Public: 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
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• 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
• Device Model Number: IT1054096B
• Device Catalogue Number: IT1054096B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 07/20/2018
• 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