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

Model Number	LA1054096
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The trilogy100 ventilator was returned to the third-party 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 allegation of serious or permanent harm or injury.The device was not in use on a patient at the time of the occurrence.The device was returned to the third-party service center for investigation.During evaluation, evidence of (foam degradation inside the assembly, deteriorated foam) was present.There were no repairs performed and the device was scrapped.

• Brand Name: TRILOGY 100
• 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: 24556769
• Report Number: 2518422-2026-008709
• Device Sequence Number: 15807992
• Product Code: CBK
• UDI-Device Identifier: 00606959022836
• UDI-Public: (01)00606959022836
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: LA1054096
• Device Catalogue Number: LA1054096
• Device Lot Number: 120217
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1956-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown