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

Model Number	1040005B
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the positive flow verify test step had failed on a trilogy 100 device.The device was not in use on a patient at the time of the occurrence.The trilogy 100 device was evaluated at the manufacturer service center.During the evaluation it was noted that there was a calibration of the device that had caused this particular test case to fail on the device.In conclusion, the device was recalibrated to address the issue.The device was retested and had failed the repair testing on the device.Philips is currently investigating this complaint.The device is still being evaluated by the manufacturer service center and is currently awaiting evaluation.A supplemental report will be submitted as due.
Additional Manufacturer Narrative
The manufacturer received information alleging the positive flow verify test step had failed on a trilogy 100 device.The device was not in use on a patient at the time of the occurrence.The trilogy 100 device was evaluated at the manufacturer service center.During the evaluation it was noted that there was a calibration of the device that had caused this particular test case to fail on the device.In conclusion, the device was recalibrated to address the issue.The device was retested and had failed the repair testing on the device.The device was re-evaluated, but the failed test could not be confirmed on the device.There were no repairs to the device, and there were no parts replaced for this issue.The device passed all final testing.

• Brand Name: TRILOGY 200
• 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: 23658860
• Report Number: 2518422-2025-112135
• Device Sequence Number: 21338869
• Product Code: CBK
• UDI-Device Identifier: 00606959026445
• UDI-Public: (01)00606959026445
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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: 1040005B
• Device Catalogue Number: 1040005B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2013
• 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