MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 02; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number R1040004TP

Device Problems Circuit Failure (1089); Communication or Transmission Problem (2896)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging a "ventilator service required" alarm condition occurred.There was no harm or injury reported.During the initial evaluation of the trilogy 02, at the manufacturer's service center, the reported issue was duplicated.Error code e-344 was found in the ventilator's downloaded error log.The device's oxygen blending module board/pca will be replaced to address the issue once the part becomes available.Parts are on back order, so the repair completion date has not been set.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: TRILOGY 02
• 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: 18579608
• MDR Text Key: 333729098
• Report Number: 2518422-2024-04296
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959025394
• UDI-Public: 00606959025394
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Operator: Health Professional
• Device Model Number: R1040004TP
• Device Catalogue Number: R1040004TP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1