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

Model Number	BR1054096
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
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, ventilator service required error codes related to the control pressure sensor and the airstream temperature sensor were found.Err_control_press_railed means the control pressure sensor is reading maximum or minimum counts for an extended period of time.Err_airstream_temp_1_railed means the airstream temperature sensor is reading maximum or minimum counts for an extended period of time.The battery fan was listed as being replaced to address the issue.Additionally, a ventilator service required error code related to the monitor pressure sensor was found.Err_monitor_press_railed means the monitor pressure sensor is reading maximum or minimum counts for an extended period of time.This error is not considered a reportable malfunction/issue.
Event or Problem Description
A ventilator was returned to a third-party service center for service.The device was not in patient use.During the evaluation of the device at the third-party service center, ventilator service required error codes related to the control pressure sensor and the airstream temperature sensor were found.Err_control_press_railed means the control pressure sensor is reading maximum or minimum counts for an extended period of time.Err_airstream_temp_1_railed means the airstream temperature sensor is reading maximum or minimum counts for an extended period of time.The battery fan was listed as being replaced to address the issue.Additionally, a ventilator service required error code related to the monitor pressure sensor was found.Err_monitor_press_railed means the monitor pressure sensor is reading maximum or minimum counts for an extended period of time.This error is not considered a reportable malfunction/issue.
Additional Manufacturer Narrative
The manufacturer previously reported information that 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, ventilator service required error codes related to the control pressure sensor and the airstream temperature sensor were found.Err_control_press_railed means the control pressure sensor is reading maximum or minimum counts for an extended period of time.Err_airstream_temp_1_railed means the airstream temperature sensor is reading maximum or minimum counts for an extended period of time.The battery fan was listed as being replaced to address the issue.Additionally, a ventilator service required error code related to the monitor pressure sensor was found.Err_monitor_press_railed means the monitor pressure sensor is reading maximum or minimum counts for an extended period of time.This error is not considered a reportable malfunction/issue.Correction: a ventilator was returned to a third-party service center for service.The device was not in patient use.During the evaluation of the device at the third-party service center, ventilator service required error codes related to the control pressure sensor and the airstream temperature sensor were found.Err_control_press_railed means the control pressure sensor is reading maximum or minimum counts for an extended period of time.Err_airstream_temp_1_railed means the airstream temperature sensor is reading maximum or minimum counts for an extended period of time.The battery fan was listed as being replaced to address the issue.Additionally, a ventilator service required error code related to the monitor pressure sensor was found.Err_monitor_press_railed means the monitor pressure sensor is reading maximum or minimum counts for an extended period of time.This error is not considered a reportable malfunction/issue.Corrections have been made as follows : general information section, become aware date field changed to 03/21/2025; section b, event date changed to 03/21/2025; section d, device serviced by 3rdp changed to yes, device avail for eval changed to no, date returned to mfg changed to na; section h, device evaluated by mfg changed to no, reason device not eval changed to device not returned to manufacturer.Coding has been updated accordingly.

• Brand Name: TRILOGY100 VENTILATOR, BRAZIL
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22125145
• Report Number: 2518422-2025-106271
• Device Sequence Number: 20709292
• Product Code: CBK
• UDI-Device Identifier: 00606959022775
• UDI-Public: (01)00606959022775
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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
• Device Model Number: BR1054096
• Device Catalogue Number: BR1054096
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2018
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown