MAUDE Adverse Event Report: Respironics, Inc. Trilogy; Ventilator, Continuous, Facility Use

Model Number	1054097
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The trilogy 100 was returned to the third-party service center for evaluation.The device was not reported to be in clinical use, and no medical intervention was specified.During evaluation, the device error log was reviewed, and the following errors were identified: e009 ¿ ventilator inoperative / motor failure: this error indicates a motor blower failure.The motor blower requires replacement.E364 ¿ internal li-ion battery fuse open: this error indicates that the internal li-ion battery fuse is open.The internal battery is the final power source and requires replacement.The device also exceeded 30,000 blower hours and was due for 30,000-hour preventive maintenance.The air path kit was noted to be missing.Based on the evaluation findings, replacement of the motor blower and internal battery would be required to address the identified conditions.No parts were replaced because the device was scrapped at the customer's request.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.
Additional Manufacturer Narrative
The reported failure of a ventilator inoperative error is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.The reported failure of the internal battery is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Device exceeds expected life.Dhr not required.

• 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 ; +1(724)733-0200
• MDR Report Key: 50944416
• Report Number: 2518422-2026-046633
• Device Sequence Number: 21419707
• Product Code: CBK
• UDI-Device Identifier: 00606959022751
• UDI-Public: (01)00606959022751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 1054097
• Device Catalogue Number: 1054097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2012
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown