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

Model Number DS2200X11B

Device Problem Failure to Power Up (1476)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging a trilogy ev300 device will not turn on.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.The customer stated their biomed department will repair the device, therefore the device will not be returned to the manufacturer for evaluation.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• 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: 18717451
• MDR Text Key: 336209685
• Report Number: 2518422-2024-07689
• Device Sequence Number: 1
• Product Code: CBK
• 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: Non-Healthcare 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: Lay User/Patient
• Device Model Number: DS2200X11B
• Device Catalogue Number: DS2200X11B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1