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

Model Number	CA2110X12B
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to the manufacturer.
Event or Problem Description
The manufacturer received information alleging a trilogy evo "ventilator inoperative condition occurred.The customer states the device turned off while being moved from a roll stand to a wheelchair bracket.The customer states the internal and external batteries were both changed and were both plugged into ac power prior to the device being moved.Once the device was unplugged to be move the device randomly turned off.There was no harm or injury reported.The device was sent to a third-party service center for evaluation.During the evaluation of the device at the third-party service center, error code e-325 was found in the ventilator's downloaded error log.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Previously reported: the manufacturer received information alleging a trilogy evo "ventilator inoperative condition occurred.The customer states the device turned off while being moved from a roll stand to a wheelchair bracket.The customer states the internal and external batteries were both changed and were both plugged into ac power prior to the device being moved.Once the device was unplugged to be move the device randomly turned off.There was no harm or injury reported.The device was sent to a third-party service center for evaluation.During the evaluation of the device at the third-party service center, error code e-325 was found in the ventilator's downloaded error log.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.New information: correction to section b5: the manufacturer received information alleging a trilogy evo "ventilator inoperative condition occurred.The customer states the device turned off while being moved from a roll stand to a wheelchair bracket.The customer states the internal and external batteries were both changed and were both plugged into ac power prior to the device being moved.Once the device was unplugged to be move the device randomly turned off.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a trilogy evo "ventilator inoperative condition occurred.The customer states the device turned off while being moved from a roll stand to a wheelchair bracket.The customer states the internal and external batteries were both changed and were both plugged into ac power prior to the device being moved.Once the device was unplugged to be move the device randomly turned off.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The ventilator was evaluated by third party service center and the customer's complaint was not reproduced.The device passes the test.

• Brand Name: TRILOGY EVO
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18746954
• Report Number: 2518422-2024-08789
• Device Sequence Number: 11721962
• Product Code: CBK
• UDI-Device Identifier: 00606959052307
• UDI-Public: 00606959052307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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: CA2110X12B
• Device Catalogue Number: CA2110X12B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: Not provided; 05/23/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2021
• 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