MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; PORTABLE ELECTRIC VENTILATOR

Model Number	1032800
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
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, the device failed a test step related to pressure.The device was requested to return unrepaired to the customer.The sound abatement foam was replaced preventatively.
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.

• Brand Name: TRILOGY 200
• 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: 24779167
• Report Number: 2518422-2026-111910
• Device Sequence Number: 9904566
• Product Code: CBK
• UDI-Device Identifier: 00606959022683
• UDI-Public: 00606959022683
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: 1032800
• Device Catalogue Number: 1032800
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2024
• Initial Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 05/13/2010
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown