MAUDE Adverse Event Report: Respironics, Inc. TRILOGY EVO EU; Ventilator, Continuous, Facility Use

Model Number	EU2110X15B
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator was returned to a third-party service center for evaluation.No patient involvement or harm was reported.During the preliminary "inprocess" evaluation of the device at the third-party service center, an error code 059, evt_battery_not_charging_fault, indicated a hardware fault preventing the internal or detachable li-ion battery from charging.The detachable battery was determined to require replacement.Additionally, the device had a non-actionable error code for 330-sensor offset during drift calculation is too high and 386-machine flow sensor offset greater.Evaluation/repair of the device is anticipated but has not yet begun because the service provider is awaiting customer approval of the service quotation.The manufacturer's investigation is ongoing.If additional relevant information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was evaluated at a third-party service center, where error code 059 (evt_battery_not_charging_fault) was confirmed in the device log.Based on the error log, the service technician determined that the vent check was triggered by a faulty detachable battery, and replacement of the detachable battery was recommended.The non-actionable error codes 330 and 386 it was recommended replacement of the system printed circuit assembly (pca) and machine flow sensor.As part of the required four-year preventive maintenance (pm), the air inlet foam filter, muffler, and particulate filter were replaced, and a pm label was added to the device.Following service, the device was inspected and tested and met all applicable acceptance criteria and customer requirements.All required test results passed.The reported failure of error code 059 (evt_battery_not_charging_fault) 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.Dhr review was performed for the complaint device sn (b)(6).Review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: TRILOGY EVO EU
• 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: 50917271
• Report Number: 2518422-2026-046526
• Device Sequence Number: 20166060
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181166
• 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
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2021
• 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