MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; PORTABLE ELECTRIC VENTILATOR

Model Number	1054096B
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The capa process identified complaints not being created for quality issues found during third party servicing.Based on a review of records impacted by the identified issue, it was determined that this record needed to be corrected and is now being submitted accordingly.The reported failure of the active exhalation purge valve closed test step is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of 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.
Event or Problem Description
A trilogy 100 ventilator was returned to a third-party service center for foam remediation on the device.There was no harm or injury reported.There was no evidence that the device was in patient use.During the evaluation of the device at the third-party service center, the device failed an active exhalation purge valve closed test step.No further testing was performed.The device was visually inspected and found no evidence of foam degradation.Additionally, not related to the reportable event the device was alarming for a circuit disconnect alarm condition.The tubing was checked to address the issue.This would not affect the device's ability to deliver therapy as designed.The sound abatement foam was replaced preventatively.The device was returned for remediation only and was returned to the customer unrepaired.

• Brand Name: TRILOGY 100
• Common Device Name: PORTABLE ELECTRIC VENTILATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 25092207
• Report Number: 2518422-2026-112916
• Device Sequence Number: 9991153
• Product Code: CBK
• UDI-Device Identifier: 00606959026469
• UDI-Public: (01)00606959026469
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 1054096B
• Device Catalogue Number: 1054096B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2020
• 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