MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO O2; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	SP2100X26B
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The trilogy device was sent to a third-party service center for evaluation.During the evaluation of the device at the third-party service center, an error code was found in the ventilator's downloaded error log.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: TRILOGY EVO O2
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19200091
• Report Number: 2518422-2024-23236
• Device Sequence Number: 20815024
• Product Code: CBK
• UDI-Device Identifier: 00606959057456
• UDI-Public: 00606959057456
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial

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: SP2100X26B
• Device Catalogue Number: SP2100X26B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2020
• 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