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

Model Number	BT1054260
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator 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, the active exhalation control module had a test failure.The customer requested that no repairs be done to the unit.The unit will be returned to the customer unrepaired.Additionally, the overlay was scratched cosmetically, and the feet needed to be replaced.The inlet air path assembly and removable air path foam were replaced per remediation.

• Brand Name: TRILOGY 100 VENTILATOR
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18544945
• Report Number: 2518422-2024-03551
• Device Sequence Number: 8915441
• Product Code: CBK
• UDI-Device Identifier: 00606959023178
• UDI-Public: 00606959023178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• 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: BT1054260
• Device Catalogue Number: BT1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2015
• 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