MAUDE Adverse Event Report: Respironics, Inc. Trilogy EV300, USA; Ventilator, Continuous, Facility Use

Model Number	DS2200X11B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a failed test step occurred on a trilogy ev300 ventilator.The device was not in use on a patient at the time of the occurrence.The trilogy ev300 ventilator was evaluated by a third-party service center (general biomedical service inc) and the customer¿s states the preventative maintenance is failing the aecm portion of the system final test.The manufacturer remote service engineer reviewed the service manual and suggested repair for the failed test.The customer is taking responsibility to correct/repair the device.The remote service engineer noted: the system does not meet the specification for the performed service and is not returned to use.The customer has been notified to contact philips if the repair recommendations does not address the device issue at which point a new service order will be created.The remote service engineer noted: no further information will be obtained as this concluded philips remote support to the customer for this event.A good faith effort attempt will be made to gather additional information from the customer regarding the repair of the device.If additional information becomes available, a supplemental report will be filed.

• Brand Name: Trilogy EV300, USA
• 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: 50951015
• Report Number: 2518422-2026-046694
• Device Sequence Number: 10446778
• Product Code: CBK
• UDI-Device Identifier: 00606959052017
• UDI-Public: (01)00606959052017
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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
• Operator of Device: Other
• Device Model Number: DS2200X11B
• Device Catalogue Number: DS2200X11B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown