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

Model Number	1032800B
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
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 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, the device failed to power on.The device was requested to return unrepaired to the customer.The sound abatement foam was replaced preventatively.

• Brand Name: TRILOGY 200 VENTILATOR, INTL - 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: 24973426
• Report Number: 2518422-2026-112535
• Device Sequence Number: 12000361
• Product Code: CBK
• UDI-Device Identifier: 00606959026360
• UDI-Public: (01)00606959026360
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093416
• 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): 04/23/2026

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: 1032800B
• Device Catalogue Number: 1032800B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2016
• 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