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

Model Number	1040005B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Failure to Calibrate (2440); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The trilogy 100 ventilator was returned to the manufacturer service center for preventative maintenance.The device was not in use on a patient at the time of the occurrence.During the evaluation it was noted the device returned to the technician for additional evaluation due to a critical error code in relation to (dsp_motor_failure).In conclusion the device internal battery pack needs to be replaced to resolve the issue.There are no battery packs in stock, and the unit will be placed on wait until the part become available.Additionally, during the service of the device, components were replaced as part of cosmetic or physical damage of the device unrelated to the reportable malfunction/issue.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the trilogy 100 ventilator was returned to the manufacturer service center for preventative maintenance.The device was not in use on a patient at the time of the occurrence.During the evaluation it was noted the device returned to the technician for additional evaluation due to a critical error code in relation to (dsp_motor_failure).In conclusion the device internal battery pack needs to be replaced to resolve the issue.There are no battery packs in stock, and the unit will be placed on wait until the part become available.Additionally, during the service of the device, components were replaced as part of cosmetic or physical damage of the device unrelated to the reportable malfunction/issue.If any additional information is received, a follow-up report will be filed.New information: during the evaluation it was noted the device returned to the technician for additional evaluation due to a critical error code in relation to (dsp_motor_failure).In conclusion the device internal battery pack was replaced to resolve the issue.Additionally, the device failed a detachable battery test step unrelated to the reported malfunction.The detachable battery is currently not available therefore the device was sent back to the customer until inventory becomes available.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the trilogy 100 ventilator was returned to the manufacturer service center for preventative maintenance.The device was not in use on a patient at the time of the occurrence.During the evaluation it was noted the device returned to the technician for additional evaluation due to a critical error code in relation to (dsp_motor_failure).In conclusion the device internal battery pack needs to be replaced to resolve the issue.There are no battery packs in stock, and the unit will be placed on wait until the part become available.Additionally, during the service of the device, components were replaced as part of cosmetic or physical damage of the device unrelated to the reportable malfunction/issue.The internal battery pack later became available and was replaced to resolve the issue.The device was returned to the technician for additional testing and failed a detachable battery test step unrelated to the reported malfunction.The detachable battery is currently not available therefore the device will be sent back to the customer until inventory becomes available.New information: the device was returned to the technician for additional testing due to a failed repair test.The device failed the monitor pressure verification test step and will require recalibration on the test station.The device will be sent to run in and will be retested.If any additional information is received, a follow-up report will be filed.Box h coding was updated.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the trilogy 100 ventilator was returned to the manufacturer service center for preventative maintenance.The device was not in use on a patient at the time of the occurrence.During the evaluation it was noted the device returned to the technician for additional evaluation due to a critical error code in relation to (dsp_motor_failure).In conclusion the device internal battery pack needs to be replaced to resolve the issue.There are no battery packs in stock, and the unit will be placed on wait until the part become available.Additionally, during the service of the device, components were replaced as part of cosmetic or physical damage of the device unrelated to the reportable malfunction/issue.The internal battery pack later became available and was replaced to resolve the issue.The device was returned to the technician for additional testing and failed a detachable battery test step unrelated to the reported malfunction.The detachable battery is currently not available therefore the device will be sent back to the customer until inventory becomes available.A follow up reported: the device was returned to the technician for additional testing due to a failed repair test.The device failed the monitor pressure verification test step and will require recalibration on the test station.The device will be sent to run in and will be retested.New information: the device was returned to the technician for additional testing due to a failed repair test.The device failed the monitor pressure verification test step therefore the sensor board needs to be replaced to address the issue.The service center is waiting on the customers reply to the repair estimate.If any additional information is received, a follow-up report will be filed.

• 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: 23453479
• Report Number: 2518422-2025-111542
• Device Sequence Number: 15705395
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2026

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: 1040005B
• Device Catalogue Number: 1040005B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/29/2026; 02/06/2026; 03/23/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/05/2026; 02/09/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2015
• 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