MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	R1054655TP
Medical Device Problem Codes	Mechanical Problem (1384); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
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.The device's power management board was replaced to address the issue.Damage to the screw receiving part of the rear and front enclosure was confirmed, the rear and front enclosure was replaced.Damage was confirmed, the flow sensor assembly was replaced.The device passed final test.
Additional Manufacturer Narrative
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 power management board was replaced to address the issue.Damage to the screw receiving part of the rear and front enclosure was confirmed, the rear and front enclosure was replaced.Damage was confirmed, the flow sensor assembly was replaced.The device passed final test.The device was returned to the product investigation laboratory (pil) for further evaluation.The power management board was placed into the test bed, and the problem was not duplicated.The power management board operates on all power sources without issue or error code and provides continuous operation on all power sources.In addition, the power management board passed power source testing.Pil has determined that power management board operates as expected.The power management board was scrapped and disposed of accordingly.The device udi has been updated on this report.

• Brand Name: TRILOGY100
• 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: 18428568
• Report Number: 2518422-2024-00118
• Device Sequence Number: 12695453
• Product Code: CBK
• UDI-Device Identifier: 00606959033894
• UDI-Public: (01)00606959033894
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: R1054655TP
• Device Catalogue Number: R1054655TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2017
• 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