VantageView™ System (REF VS100005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067010865), received between Nov 8, 2019 and Aug 2, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Communication or Transmission Problem; Communication or Transmission Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263537 ↗
• InjuryAug 5, 2020No Display/Image; No Display/Image

  DURING THE PROCEDURE, WHEN ATTEMPTING TO CHANGE VIDEO SOURCES AND SWITCH PRESETS ON THE SYSTEM VIA THE TABLET, THE SOURCE WOULD NOT APPEAR RESULTING IN A SIGNIFICANT DELAY IN PROCEDURE. THE SERVER RACK WAS REBOOTED, THE UPS WAS RESET AND THE ROUTER WAS RESET. FOLLOWING THIS RESET, EVERYTHING INITIALLY DISPLAYED ON THE TABLET AS EXPECTED BUT THREE MORE OUTPUT SOURCES WERE LOST. SINCE THIS OCCURRED DURING THE PROCEDURE, THE OUTPUT SOURCES COULD NOT BE POWER-CYCLED. SECONDARY MONITORS WERE USED TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366882 ↗
• InjuryNov 8, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A RED TINT WAS NOTED ON THE LEFT HALF OF THE SCREEN AND THE TABLET WAS BOOTING UP TO A (B)(6) ERROR MESSAGE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME AND TROUBLESHOOTING CAUSED A CLINICALLY SIGNIFICANT DELAY. THE ISSUE WAS EVENTUALLY RESOLVED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9294949 ↗