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

Model Number	1040005
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
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 manufacturer received information that a trilogy 200 ventilator was returned in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The device is being returned for foam replacement per fsca 2021-05-a.There was no patient involvement, and no harm or injury reported.Evaluation of the device confirmed a ventilator inoperative message.No additional information regarding the ventilator inoperative message is available at this time.Additional findings not related to the malfunction/ventilator inoperative issue: the rubber feet were missing from the device and would need to be replaced.The device had an safety data card read failure that would require replacement of the system and central processing unit circuit board assemblies.The rear case enclosure will need to be replaced due to physical damage.The handle kit will need to be replaced due to detaching handle grip /physical damage.The blower motor is seized up and will not rotate.
Additional Manufacturer Narrative
It was previously reported that the manufacturer received information that a trilogy 200 ventilator was returned in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The device is being returned for foam replacement per fsca 2021-05-a.There was no patient involvement, and no harm or injury reported.Evaluation of the device confirmed a ventilator inoperative message.No additional information regarding the ventilator inoperative message is available at this time.Additional findings not related to the malfunction/ventilator inoperative issue: the rubber feet were missing from the device and would need to be replaced.The device had an safety data card read failure that would require replacement of the system and central processing unit circuit board assemblies.The rear case enclosure will need to be replaced due to physical damage.The handle kit will need to be replaced due to detaching handle grip /physical damage.The blower motor is seized up and will not rotate.Additional information was received 17 dec 2025 informing the manufacturer the device was returned to the technician for addition evaluation due to a failed repair test.No additional information is available at this time.A follow up report will be submitted upon receipt of additional information regarding the newly reported device evaluation test failure.No updates to the coding grid have been made at this time.
Additional Manufacturer Narrative
It was previously reported that the manufacturer received information that a trilogy 200 ventilator was returned in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The device is being returned for foam replacement per fsca 2021-05-a.There was no patient involvement, and no harm or injury reported.Evaluation of the device confirmed a ventilator inoperative message.No additional information regarding the ventilator inoperative message is available at this time.Additional findings not related to the malfunction/ventilator inoperative issue: the rubber feet were missing from the device and would need to be replaced.The device had a safety data card read failure that would require replacement of the system and central processing unit circuit board assemblies.The rear case enclosure will need to be replaced due to physical damage.The handle kit will need to be replaced due to detaching handle grip /physical damage.The blower motor is seized up and will not rotate.Additional information was received 17 dec 2025 informing the manufacturer the device was returned to the technician for addition evaluation due to a failed repair test.No additional information is available at this time.Additional information was received 06 january 2026 informing the manufacturer the previously reported failed repair test has been identified as the device failed testing due to "check clock settings".This test checks for the device real time clock time and does not affect therapy.The technician confirmed the test failure and reported the real time clock has been reset per procedure.There is no additional reportable device issue and no change to the previously submitted coding grids necessary.
Additional Manufacturer Narrative
It was previously reported that the device had a ventilator inoperative message that could not be identified with an error code.The blower motor was reportedly seized up and would not rotate.Additional findings not related to the malfunction/ventilator inoperative issue: the rubber feet were missing from the device and would need to be replaced.The error logs were not able to be read.The device had a safety data card read failure that would require replacement of the system and central processing unit circuit board assemblies.The rear case enclosure will need to be replaced due to physical damage.The handle kit will need to be replaced due to detaching handle grip /physical damage.The blower motor is seized up and will not rotate.Additional information was received 17 dec 2025 informing the manufacturer the device was returned to the technician for addition evaluation due to a failed repair test.No additional information is available at this time.Additional information was received 06 january 2026 informing the manufacturer the previously reported failed repair test has been identified as the device failed testing due to "check clock settings".This test checks for the device real time clock time and does not affect therapy.The technician confirmed the test failure and reported the real time clock has been reset per procedure.Additional information was obtained 30 january 2026.It was confirmed by the service center technician that the ventilator inoperative condition initially reported was caused by the blower being seized up and unable to move.The blower assembly was replaced to address this issue.The device was re-tested and passed all testing.The coding grid has been updated to correctly reflect the additional information reported.

• 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: 23714098
• Report Number: 2518422-2025-112281
• Device Sequence Number: 13327079
• Product Code: CBK
• UDI-Device Identifier: 00606959022737
• UDI-Public: (01)00606959022737
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/01/2026

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: 1040005
• Device Catalogue Number: 1040005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/06/2026; Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/09/2026; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2012
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown