KODEX-EPD System 733015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838095229), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP: PHILIPS HAS INVESTIGATED THIS COMPLAINT AND CONFIRMED THAT THERE WAS NOT MALFUNCTION OF THE EPD KODEX SYSTEM. PATIENT WAS UNDERGOING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA SLOW PATHWAY ABLATION PROCEDURE WITH THE ANATOMY AND KEY ELECTRICAL CONDUCTION SYSTEM MAP GUIDED BY THE EPD KODEX 3D SYSTEM, FLUOROSCOPY, AND A STANDARD ELECTRO PHYSIOLOGY RECORDING SYSTEM. DURING THE PROCEDURE THE PATIENT DEVELOPED RIGHT BUNDLE BRANCH BLOCK. 24 HOURS POST PROCEDURE, THE PATIENT DEVELOPED PR PROLONGATION 300MSEC WHICH 48 HOURS LATER DEVELOPED TO 2:1 ATRIOVENTRICULAR BLOCK WITH INTERMITTENT LEFT BUNDLE BRANCH BLOCK. A PACEMAKER WAS IMPLANTED TO TREAT THIS CONDITION. THE ANALYSIS OF THE CASE FILES BY PHILIPS SHOWS FREQUENT ABRUPT CHANGES IN THE RESPIRATION PROFILE AS WELL AS PATIENT MOVEMENTS THROUGHOUT THE PROCEDURE. THE ¿ABRUPT RESPIRATION¿ INDICATOR WAS DISPLAYED BY THE EPD KODEX SYSTEM ALERTING THE PHYSICIAN OF THE RESPIRATORY DRIFTS AND MOVEMENTS. AN ADDITIONAL ALERT WAS ALSO GIVEN THROUGH FLUOROSCOPY. THESE ALERTS WERE ACKNOWLEDGED BY THE PHYSICIAN WHO CONTINUED WITH THE ABLATION PROCEDURE. THE EPD KODEX SYSTEM IS DESIGNED TO COMPENSATE RESPIRATORY DRIFTS AND GRADUAL MOVEMEN

  Patient problems: Heart Block

  MAUDE report 11044937 ↗