MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100 VENTILATOR, JAPAN - BT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1054655B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of ventilator inoperative error code err_dsp_motor_failure 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.The device mentioned in this complaint has exceeded its useful life per the applicable ifu.
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction, and the device was not in patient use.The trilogy 100 ventilator, japan - bt device was evaluated at the manufacturer, and a ventilator inoperative error code err_dsp_motor_failure was discovered in the device's event log.The device's blower motor assembly and system board were replaced to address the issue.In conjunction with replacement of the blower motor assembly, the stirring fan foam was also replaced.Following repair, the technician performed repair testing, alarm check, battery check, run-in testing, and cleaning.The device was confirmed to be operating properly.Software version 14.2.05 was verified.

• Brand Name: TRILOGY 100 VENTILATOR, JAPAN - BT
• 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: 25291949
• Report Number: 2518422-2026-016743
• Device Sequence Number: 10094890
• Product Code: CBK
• UDI-Device Identifier: 00606959052345
• UDI-Public: (01)00606959052345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 1054655B
• Device Catalogue Number: 1054655B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2019
• 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