MAUDE Adverse Event Report: ST. JUDE MEDICAL VANTAGEVIEW, 16 CHANNEL SYSTEM, 120V; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Model Number VS100005

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/15/2021

Event Type  malfunction  

Event Description

Prior to the ventricular tachycardia (vt) procedure, after the patient was prepped, the maclab live signal was not displaying on the vantageview monitor.Rebooting the rack and the power converter did not resolve the issue.A media convertor was found to be the issue.The patient was prepped and procedure was cancelled.There were no adverse patient consequences.

Manufacturer Narrative

The product was not returned however, a replacement was sent, but is unknown if it resolved the issue.This device history record was completed by a representative from avi.Everything passed vendor and manufacture testing.Based on the information received, the cause of the reported incident could not be conclusively determined.If the issue persists it is recommended to return the product for evaluation. .

• Brand Name: VANTAGEVIEW, 16 CHANNEL SYSTEM, 120V
• Type of Device: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12263537
• MDR Text Key: 264693438
• Report Number: 2184149-2021-00240
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 05415067010865
• UDI-Public: 05415067010865
• Combination Product (y/n): N
• PMA/PMN Number: K110085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VS100005
• Device Catalogue Number: VS100005
• Device Lot Number: 7720196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Patient Sequence Number: 1