MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	R1054260
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, an error code related to the charging of the internal battery was observed.At this time the evaluation and repair have not been completed.A supplemental report will be sent when it has been completed.
Additional Manufacturer Narrative
On previously submitted report, a ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, an error code related to the charging of the internal battery was observed.The device's internal battery needs to be replaced to address the issue.No repairs performed.The unit will be scrapped.

• Brand Name: TRILOGY 100
• 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: 18285026
• Report Number: 2518422-2023-34190
• Device Sequence Number: 5909929
• Product Code: CBK
• UDI-Device Identifier: 00606959026308
• UDI-Public: 00606959026308
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: R1054260
• Device Catalogue Number: R1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2013
• 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