BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP WORKMATE

    MDR report key: 564724 · Received December 24, 2004

    Report

    Report Number
    564724
    Event Type
    Malfunction
    Date Received
    December 24, 2004
    Date of Event
    December 8, 2004
    Report Date
    December 24, 2004
    Manufacturer
    EPMEDSYSTEMS, INC.
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS PER FDA'S REQUEST PROVIDED TO EP MEDYSYSTEMS, INC. IN FDA REPORT 3600520000-2004-8003. THE ACUAL DEVICE EP WORKMATE COMPUTER WAS INSPECTED AND TESTED BY EPMEDSYSTEMS AT THE USER FACILITY ON 012405; THE CUSTOMER REQUETED THE DELAY OF THE SERVICE VISIT FROM DECEMBER TO JANUARY. NO PROBLEMS WERE FOUND WITH SYSTEM OPERATION; IT DID NOT APPEAR UNRESPONSIVE DURING ON-SITE TESTING OR DURING USE IN A PT CASE. ECG CABLE DRESSING BY THE USER WAS PROBLEMATIC; THIS WAS UNRELATED TO THE PURPORTED PROBLEM A FIELD SERVICE REPORT WAS COMPLETED FOR THE 012405 VISIT (ATTCH A). CONCURRENTLY, THE SYSTEM EVENT LOG WAS DOWNLOADED REMOTELY BY EP MEDSYSTEMS ENGINERING TO THE LAB. PURPORTED SYSTEM BEHAVIOR ON 120804 WAS CONFIRMED (ATTCH B: EVENT LOG). PRIOR TO THE EVENT, TESTING BY EP MEDSYSTEMS WITH SIMILAR SETUPS INCLUDING A STOCKERT RF GENERATOR CONFIRMED SERIAL DATA OUTPUT BY STOCKERT WAS SOMETIMES CORRUPTED DURING ABLATION BY THE STOCKERT'S CONDUCTED EMI; THIS IS CAPABLE OF INTERMITTENTLY CAUSING ELEMENTS OF THE EP WORKMATE SYSTEM (E.G, REVIEW SCREEN, MOUSE) TO APPEAR UNRESPONSIVE AS IT ATTEMPTS TO PROCESS CORRUPT DATA. THE EP WORKMATE SERIAL PORT IS COMPLIANT WITH IEC 60601-1-2 EMC IMMUNITY CRITERIA. AN OPTIONAL EMI SERIAL PORT FILTER WAS PROVIDED TO THE END USER IN 7/2004. IT WAS NOT NOTED AT THE TIME OF THE MALFUNCTION IF THE FILTER WAS INSTALLED. SUBSEQUENTLY, EP MEDSYSTEMS ENGINEERING CHANGE REQUEST (ECR) 200 (ATTCH C), ITEM #8, IMPLEMENTED A SOFTWARE UPDATE TO RESET THE SERIAL PORT THEREBY IGNORING THE NEGATIVE EFFECTS OF EXCESSIVE EMI CORRUPTING THE SERIAL DATA OUTPUT BY STOCKERT GENERATOR IN SOFTWARE REVS 3.2.4 AND HIGHER. THE CUSTOMER'S SOFTWARE WAS UPDATED TO REVISION 3.2.5 THAT WAS THE CURRENT REVISION AT THE TIME OF THE SERVICE CALL.

    Description of Event or Problem · 1

    PERFORMING AN ABLATION USING SPECIAL EQUIPMENT: USING A 3D MAPPING SYSTEM WITH AN 8 MM TIP ABLATION CATHETER. DURING PROCEDURE THE HEART WAS BEING PACED. PHYSICAN WANTED TO STOP PACING AND THE KEYPAD LOCKED UP. UNABLE TO STOP PACING PER KEYPAD - USED TOUCH SCREEN. REVIEW SCREEN ALSO LOCKED UP. HAD TO COMPLETELY SHUT DOWN THE COMPUTER DURING THE PROCEDURE - TOOK SEVERAL MINUTES. COMPUTER LOCKED UP AGAIN WHILE ABLATING. COMPUTER CAME BACK ON ITS OWN AFTER SEVERAL MINUTES. EARLIER IN THE CASE WHILE PACING, THE SCREEN WAS BLANKING OUT ABOUT 2-3 INCHES AFTER THE PACING SPIKE. PROCEDURE WAS FINISHED WITHOUT COMPLICATIONS TO PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP WORKMATE COMPUTERIZED EP LAB RECORDING SYSTEM DXG EPMEDSYSTEMS, INC. EP WORKMATE *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR