WorkMate Claris™ H701703Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067017031), received between Jan 8, 2019 and Jun 2, 2021 — classified as 1 injury, 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K132073, K151911, K210392); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2021Output Problem; Output Problem

  DURING AN ATRIAL FIBRILLATION (AF) PROCEDURE, THE BASELINE WAS DISPLAYED IN REAL TIME, BUT AN ERROR MASSAGE "AMPLIFIER ERRORS" WAS DISPLAYED. WHEN "CLEAR ERRORS" WAS PRESSED THIS DID NOT RESOLVE THE ISSUE. THE AMPLIFIER AND DWS WERE POWER CYCLED WITH NO RESOLUTION. THE OPTICAL CABLE WAS EXCHANGED AND REBOOT WAS DONE. AN ERROR MESSAGE "AMPLIFIER ERRORS" WAS STILL DISPLAYED. HOWEVER, WHEN "CLEAR ERRORS" WAS PRESSED, "AMPLIFIER CONNECTED" WAS DISPLAYED. THE PROCEDURE CONTINUED, AND SUDDENLY, AN ERROR MASSAGE "AMPLIFIER DISCONNECTED" WAS DISPLAYED, AND NO WAVEFORM WAS DISPLAYED ON THE REAL-TIME SCREEN. THE CONNECTION OF THE OPTICAL CABLE WAS CHECKED, BUT THERE WAS NO PROBLEM, AND "CLEAR ERRORS" WAS GRAYED OUT AND COULD NOT BE PRESSED. WHEN "RESTART" WAS PRESSED AND A REBOOT WAS ATTEMPTED, THE PROBLEM DID NOT CHANGE AT FIRST, BUT AFTER 4-5 REBOOTS, COMMUNICATION WAS ESTABLISHED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE SYSTEM AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. A DELAY OCCURRED DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919390 ↗
• InjuryJan 8, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, WHEN THE CPU AND THE AMPLIFIER WERE PROPERLY CONNECTED AND THE PATCHES FOR THE 12-LEAD BODY SURFACE ECG WERE ATTACHED TO THE PATIENT, AN ERROR MESSAGE "AMPLIFIER ERRORS" WAS DISPLAYED AND THE WAVEFORM DID NOT DISPLAY AT ALL. THE SYSTEM BECAME CONNECTED WHEN "CLEAR ERROR" WAS PERFORMED THROUGH THE COMMUNICATION TEST, HOWEVER, THE ERROR WAS AGAIN DISPLAYED. THE AMPLIFIER AND CPU WERE POWER CYCLED WITH NO RESOLUTION. THE PROCEDURE WAS ABANDONED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132073, K151911, K210392. One submission often covers many models, so check the product and lot details in each record.

• Z-1853-2021 · May 5, 2021 · Terminated
  v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitorin
• Z-1855-2021 · May 5, 2021 · Terminated
  WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
• Z-1854-2021 · May 5, 2021 · Terminated
  v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording an