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

Model Number	1040000
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Failure to Calibrate (2440); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a malfunction occurred on a trilogy ev300 device, in which the ventilator did not deliver the selected volumes in any ventilation mode and displayed a message indicating the device needs servicing.No patient impact or medical intervention was specified, and clinical use was not confirmed.Philips is currently investigating this complaint; however, the device examination has not begun because the device has not yet been returned to the manufacturer for investigation.
Additional Manufacturer Narrative
The manufacturer previously reported "the manufacturer received information alleging a malfunction occurred on a trilogy ev300 device, in which the ventilator did not deliver the selected volumes in any ventilation mode and displayed a message indicating the device needs servicing.No patient impact or medical intervention was specified, and clinical use was not confirmed." the trilogy ev300 device was returned to the manufacturer's service center for evaluation, and the customer's complaint was confirmed.During the evaluation, it was noted that the device failed the leak test and was found to have a huge leak in the sensor plate of the pneumatic circuit.In conclusion, the device's circuit board sensor was replaced to address the issue.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.

• Brand Name: TRILOGY
• 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: 24300591
• Report Number: 2518422-2026-004379
• Device Sequence Number: 9679315
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 1040000
• Device Catalogue Number: 1040000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2017
• 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