MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EV300; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number GB2200X15B

Device Problems Electrical /Electronic Property Problem (1198); Material Fragmentation (1261); Communication or Transmission Problem (2896)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : evaluation is pending further investigation and repairs.

Event Description

The manufacturer received information alleging a trilogy ev300 ventilator inoperative condition occurred.There was no harm or injury reported.This device was not in patient use and was used for training purposes.It was reported thar a screw sheared off in the case shell, an ambient light sensor fault failing pvt.The main housing was replaced to resolve the customers reported fault.Farther parts are required to resolve the ventilator inoperative alarm and damage to the device.The device was sent for further investigation and repairs.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported: the manufacturer received information alleging a trilogy ev300 ventilator inoperative condition occurred.There was no harm or injury reported.This device was not in patient use and was used for training purposes.It was reported that a screw sheared off in the case shell, an ambient light sensor fault failing pvt.The main housing was replaced to resolve the customers reported fault.Farther parts are required to resolve the ventilator inoperative alarm and damage to the device.The device was sent for further investigation and repairs.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Conclusion of the investigation: the system pcba and obm assembly were replaced to resolve the ventilator inoperative alarm.The device passed the performance verification test.New information: the main housing was returned to receiving inspection quality lab (riql) for the failure of physical damage.The failure of physical damage for the main housing cannot be further investigated to determine a root cause.

Manufacturer Narrative

The manufacturer previously reported: the manufacturer received information alleging a trilogy ev300 ventilator inoperative condition occurred.There was no harm or injury reported.This device was not in patient use and was used for training purposes.It was reported thar a screw sheared off in the case shell, an ambient light sensor fault failing pvt.The main housing was replaced to resolve the customers reported fault.Farther parts are required to resolve the ventilator inoperative alarm and damage to the device.The device was sent for further investigation and repairs.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Conclusion of the investigation: the system pcba and obm assembly were replaced to resolve the ventilator inoperative alarm.The device passed the performance verification test.

• Brand Name: TRILOGY EV300
• 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: 18501903
• MDR Text Key: 332762544
• Report Number: 2518422-2024-02223
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181166
• 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,Followup,Followup

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: Other
• Device Model Number: GB2200X15B
• Device Catalogue Number: GB2200X15B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/24/2024; 03/01/2024
• Supplement Dates FDA Received: 02/06/2024; 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1