MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VANTAGEVIEW; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

In the middle of cryo ablating our vantage view monitors in the ep control room went black.The doctor was actively cryoing patient's pathway which made it extremely dangerous for the patient, because the doctors along with our carto reps could not monitor the patient's response to the ablation.Ablation had to be stopped and the system had to be reset.Faculty called the vantage view tech support number and was told to shut down the system for a few minutes once this case was done and only if it happened again would they come to research the problem.Our (b)(6) that controls the system is still not working.

Event Description

In the middle of cryo ablating our vantage view monitors in the ep control room went black.The doctor was actively cryoing patient's pathway which made it extremely dangerous for the patient, because the doctors along with our carto reps could not monitor the patient's response to the ablation.Ablation had to be stopped and the system had to be reset.Faculty called the vantage view tech support number and was told to shut down the system for a few minutes once this case was done and only if it happened again would they come to research the problem.Our ipad that controls the system is still not working.

• Brand Name: VANTAGEVIEW
• Type of Device: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12664631
• MDR Text Key: 277464961
• Report Number: 12664631
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2021
• Patient Sequence Number: 1