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

Model Number	R1054655TP
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative maintenance 1.There was no allegation of device malfunction.The device was not in patient use.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.Since the event log verified that the error had occurred during running on ac power with the internal battery capacity having been 97%, the power management board and internal battery were replaced to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported that a ventilator was returned to the manufacturer for routine preventative maintenance 1.There was no allegation of device malfunction.The device was not in patient use.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.Since the event log verified that the error had occurred during running on ac power with the internal battery capacity having been 97%, the power management board and internal battery were replaced to address the issue.Further investigation of the power management board at the product investigation lab (pil) could not duplicate the error code "err_int_li_ion_depleted" from service.With the suspected power management board installed, it operates on all power sources without issue or error code and provides continuous operation on all power sources.In addition, suspect power management board passed power source testing at trilogy mfts.Pil has determined that power management board operates as expected.The power management board has been 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: 18639692
• Report Number: 2518422-2024-05743
• Device Sequence Number: 15442509
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 12/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2017
• 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