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

Model Number DS2200X11B

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

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging a trilogy ev300 ventilator is not recognizing the o2 sensor after trying multiple o2 sensors.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 18501475
• MDR Text Key: 332736047
• Report Number: 2518422-2024-02211
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959052017
• UDI-Public: 00606959052017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: DS2200X11B
• Device Catalogue Number: DS2200X11B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1