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

Model Number 1054260

Device Problems Contamination (1120); Failure to Cycle (1142)

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

Event Date 01/30/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator would not cycle properly.There was no harm or injury reported.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

The manufacturer previously reported receiving information alleging a ventilator would not cycle properly.There was no harm or injury reported.The device was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's blower motor, sensor board, active exhalation control module, flow sensor, and tubing need replaced to address the issue.There was evidence of contamination.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11387065
• MDR Text Key: 233962016
• Report Number: 2518422-2021-00561
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959026353
• UDI-Public: 00606959026353
• Combination Product (y/n): N
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1