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

Model Number	EE2100X15B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an out of order condition occurred.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received information alleging an out of order condition occurred.There was no harm or injury reported.The ventilator was returned to the third-party service center for evaluation and the customer¿s complaint was confirmed.There were no errors found on the device.The device's machine flow sensor and in-line proximal filter were replaced to address the issue.Additional findings not related to the malfunction/issue was the following part to be proactively on the device: air inlet foam filter.
Additional Manufacturer Narrative
The manufacturer received information alleging an out of order condition occurred.There was no harm or injury reported.The ventilator was returned to the third-party service center for evaluation and the customer¿s complaint was confirmed.There were no errors found on the device.The device's machine flow sensor and in-line proximal filter were replaced to address the issue.Additional findings not related to the malfunction/issue was the following part to be proactively on the device: air inlet foam filter.A correction is being sent due to the section h6 (evaluation method code, evaluation result code, component code grid, and conclusion code grid) were missing from the previous follow-up report that was sent has been updated in this record.

• Brand Name: TRILOGY EVO
• 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: 19990140
• Report Number: 2518422-2024-100063
• Device Sequence Number: 12869971
• Product Code: CBK
• UDI-Device Identifier: 00606959055698
• UDI-Public: (01)00606959055698
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K181166
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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: EE2100X15B
• Device Catalogue Number: EE2100X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/12/2024; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown