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

Model Number 1054260B

Device Problems Break (1069); Failure to Calibrate (2440); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

The manufacturer received information stating the trilogy 100 ventilator did not meet acceptance criteria of evaluation process for the following conditions: o2 port broken.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the device powered on and operated as it should.There were no significant event (s) in the error log.It was confirmed that the o2 port was broken, and screw hubs cracked.The trilogy rear case kit, enclosure seam gasket and trilogy plastic o2 connector were replaced to address the issue.The inlet air path assembly and removable air path foam were replaced per remediation.  the device was sent for further evaluation.The device failed pressure sensor calibration.The sensor board pca assembly was replaced to address the issue.In addition, talc was found in the transition tube and flow sensor assembly.All components were replaced.

• Brand Name: TRILOGY 100
• Type of Device: 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: 18686088
• MDR Text Key: 335191857
• Report Number: 2518422-2024-06888
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1054260B
• Device Catalogue Number: 1054260B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1