BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPT-1000XP? RF ABLATION SYSTEM

    MDR report key: 2961743 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00931
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    GXD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MFR.?, EVAL SUMMARY ATTACHED, METHODS CODES, RESULT CODES, CONCLUSION CODES. VISUAL INSPECTION OF THE EPT-1000 GENERATOR NOTED PHYSICAL DAMAGE TO THE DEVICE. LOOSE ITEMS WERE NOTED INSIDE THE DEVICE AND WERE ATTRIBUTED TO BROKEN NYLON STANDOFFS BETWEEN THE ISOM AND CPU CIRCUIT BOARDS. THERE WAS NO TAMPER PROOF SEAL ON THE UNIT. DURING INVESTIGATION, IT WAS NOTED THAT THE DEVICE FAILED TO POWER ON DURING INITIAL POWER-ON SELF-TEST (POST). FOLLOWING REMOVAL OF THE DEVICE'S TOP ENCLOSURE, IT WAS NOTED THAT THE POWER SUPPLY WAS BURNED OUT AND THE TWO POWER ENTRY MODULE FUSES MEASURED OPEN. THE ROOT CAUSE OF THE COMPLAINT WAS ATTRIBUTED TO A FAILED/BURNED OUT POWER SUPPLY. THE TRANSFORMER'S PRIMARY WINDING OF THE LOW VOLTAGE POWER SUPPLY SHOWED EVIDENCE OF OVERHEATING. THIS LIKELY RESULTED IN EXCESS CURRENT DRAW, CAUSING THE POWER ENTRY MODULE FUSES TO OPEN TO PREVENT FURTHER DAMAGE. FOLLOWING REPLACEMENT OF THE POWER SUPPLY AND THE TWO POWER ENTRY MODULE FUSES, THE EPT-1000 GENERATOR PASSED POWER-ON SELF-TEST (POST) AND ALL PERFORMANCE CRITERIA OF THE FINAL TEST PROCEDURE. NO OTHER PROBLEMS WERE FOUND WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS WEAR AND TEAR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ELECTROPHYSIOLOGY TREATMENT PROCEDURE, SMOKE CAME OUT OF THE GENERATOR. AFTER THE PROCEDURE, THE EPT-1000XP GENERATOR MADE A "BANG" SOUND AND THERE WAS "SMOKE AND A BURNING SMELL" NOTED. THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ELECTROPHYSIOLOGY TREATMENT PROCEDURE, SMOKE CAME OUT OF THE GENERATOR. AFTER THE PROCEDURE, THE EPT-1000XP GENERATOR MADE A "BANG" SOUND AND THERE WAS "SMOKE AND A BURNING SMELL" NOTED. THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65448 EPT-1000XP? RF ABLATION SYSTEM GENERATOR, LESION, RADIOFREQUENCY GXD BOSTON SCIENTIFIC - SAN JOSE M004805XPZ0

    Patients

    Seq Age Sex Outcome Treatment
    1