EP-WorkMate™ SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067003119), received between Aug 8, 2018 and Apr 5, 2021 — classified as 2 injuries, 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Failure to Analyze Signal; Failure to Analyze Signal

  DURING AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) PROCEDURE, INTRACARDIAC SIGNALS WERE NOT VISIBLE WHEN THE AMPLIFIER WAS CONNECTED AND THE CASE WAS CANCELLED. THE FEMORAL VEIN WAS PUNCTURED AND CATHETERS WERE INSERTED AND NO INTRACARDIAC ELECTROGRAMS WERE NOTED. THE SYSTEM WAS RESTARTED 3 TIMES WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS POSTPONED. ANOTHER SYSTEM WAS USED TO COMPLETE THE CASE THE NEXT DAY WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614835 ↗
• InjurySep 9, 2020Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE, THE AMPLIFIER WOULD NOT BOOT UP AND ONE SINGLE CONTINUOUS BEEP WAS HEARD AND THE PROCEDURE WAS CANCELLED. THE AMPLIFIER WAS REBOOTED SEVERAL TIMES, BUT THE ISSUE REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508714 ↗
• InjuryAug 30, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE A CANCELLATION OCCURRED. FOLLOWING PATIENT PREP, THE AMPLIFIER WAS POWERED ON AND INTERMITTENT CONNECTION OCCURRED. THE AMPLIFIER AND MEDIA CONVERTER WERE POWER CYCLED WITHOUT RESOLUTION. THE FIBER OPTIC AND ETHERNET CABLES WERE REPLACED AND THE ISSUE STILL DID NOT IMPROVE. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950654 ↗
• MalfunctionNov 2, 2018Smoking; Smoking

  WHEN THE AMPLIFIER WAS POWERED ON SMOKE WAS EMITTED. THERE WERE NO PATIENT OR USER ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033794 ↗
• MalfunctionAug 8, 2018Sparking; Sparking

  PRIOR TO AN ELECTROPHYSIOLOGY PROCEDURE, THE AMPLIFIER DISPLAYED THE MESSAGE ¿NO DISPLAY - PLEASE CHECK CONNECTION¿ AND A SPARK WAS OBSERVED FOLLOWED BY A BURNING SMELL. THE AMPLIFIER WAS POWER CYCLED AND A LOUD CONTINUOUS BEEPING SOUND CAME FROM THE AMPLIFIER. THE PATIENT WAS MOVED TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761424 ↗