MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR, BRAZIL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	BR1054096
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report that a trilogy 100 ventilator was returned for evaluation.No patient injury or serious harm was reported.The device was evaluated at a manufacturer service center.A visual inspection was performed, and no evidence of foam particles or foam degradation was observed.The device was unable to read data and would not power on.No documentation regarding prior component replacement was available.No repair activities were performed, and the device was scrapped.A final report is being submitted.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
The reported failure of the device would not power on 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.Multiple service activities occur during the device's useful life according to the device's service manual.

• Brand Name: TRILOGY100 VENTILATOR, BRAZIL
• 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: 25431963
• Report Number: 2518422-2026-019994
• Device Sequence Number: 10189648
• Product Code: CBK
• UDI-Device Identifier: 00606959022775
• UDI-Public: (01)00606959022775
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: BR1054096
• Device Catalogue Number: BR1054096
• Device Lot Number: D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2012
• 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