EP-WorkMate™ Recording SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067000965), received between Jun 26, 2018 and May 9, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Output Problem; Output Problem

  DURING A PROCEDURE, THE WORKMATE CLARIS COMPUTER DISPLAYED AN ERROR MESSAGE AND THE PROCEDURE WAS CANCELLED. THE OLD WORKMATE SYSTEM WAS REPLACED BY THE NEW ENSITE X VERSION OF WORKMATE CLARIS. THE ERROR MESSAGE THAT DISPLAYED WAS ERROR MESSAGE: "162-SYSTEM OPTIONS NOT SET. THE SYSTEM CONFIGURATION HAS CHANGED SINCE THE LAST BOOT. ADDITION OF A HARD DRIVE, ETC., OR LOSS OF POWER TO THE REAL TIME CLOCK HAS OCCURRED. PRESSING F1 WILL RECORD THE NEW CONFIGURATION. IF THIS MESSAGE PERSIST, YOU MAY NEED TO REPLACE THE ONBOARD BATTERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995035 ↗
• InjuryMay 22, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  DURING A PROCEDURE THE COMPUTER DISPLAYED A "WIN32" ERROR MESSAGE AND THE SOFTWARE STOPPED RUNNING. THE PROCEDURE WAS UNABLE TO BE COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633603 ↗
• InjuryNov 21, 2018Unexpected Shutdown; Unexpected Shutdown

  DURING A PROCEDURE, THE COMPUTER SHUT DOWN AFTER A FEW MINUTES. A REBOOT WAS ATTEMPTED MULTIPLE TIMES WITH NO RESOLUTION. THE PATIENT WAS PREPPED WITH LOCAL TEMPORAL SEDATION AND CATHETERS INSERTED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094552 ↗
• InjuryJun 26, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  DURING PREPARATION FOR AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO A SOFTWARE LOCKUP. FOLLOWING IV PLACEMENT THE PC WOULD FREEZE AND SHUTDOWN. THE ISSUE WAS NOT RESOLVED AND THE PROCEDURE WAS RESCHEDULED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7637512 ↗