MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR, LATIN AMERICA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LA1054096
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The trilogy100 ventilator, latin america device was returned for evaluation at a 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 harm or injury reported.The device was not reported to be in patient use.During the evaluation of the device at the third-party service center no visible foam particles were reported, however, a ventilator inoperative error was discovered in the device's event log.The device's motor blower assembly was replaced to address the issue.Additionally, the device's operating software upgraded.The device passed final testing.

• Brand Name: TRILOGY100 VENTILATOR, LATIN AMERICA
• 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: 24632505
• Report Number: 2518422-2026-009753
• Device Sequence Number: 18382072
• Product Code: CBK
• UDI-Device Identifier: 00606959022836
• UDI-Public: (01)00606959022836
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: LA1054096
• Device Catalogue Number: LA1054096
• Device Lot Number: 101214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2010
• 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