MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1125564B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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 200 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 service technician states that device experienced a ventilator inoperative condition and that it was retest and worked properly.There is no documentation stated on a root cause or any component replacement.The device passed final testing.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.".

• Brand Name: TRILOGY 200
• 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: 24702336
• Report Number: 2518422-2026-111531
• Device Sequence Number: 21442613
• Product Code: CBK
• UDI-Device Identifier: 00606959027763
• UDI-Public: (01)00606959027763
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 1125564B
• Device Catalogue Number: 1125564B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2020
• 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