BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPT-1000 TC AUTOMATIC PERSONALITY MODULE (APM)

    MDR report key: 299358 · Received October 6, 2000

    Report

    Report Number
    2939222-2000-00005
    Event Type
    Malfunction
    Date Received
    October 6, 2000
    Date of Event
    September 6, 2000
    Report Date
    September 6, 2000
    Manufacturer
    EPT/A DIVISION OF BSC
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN EP CATHETER LAB NURSE REC'D AN ELECTRICAL SHOCK (AS IF A WALL SOCKET WAS THE VOLTAGE SOURCE), WHEN DISCONNECTING THE CORDIS CABLE BETWEEN THE EPT SWITCHBOX (821T APM) AND THE BIOSENSE JUNCTION BOX. AN EPT GENERATOR AND SWITCHBOX WERE CONNECTED TO A BIOSENSE CATHETER, THROUGH THE CABLE AND JUNCTION BOX. A PRUCKA JUNCTION BOX AND PRUCKA RECORDING SYSTEM WERE ALSO USED. THE CONNECTION OF ALL OF THIS EQUIPMENT IS NOT RECOMMENDED IN EPT PRODUCTS' USER DIRECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPT-1000 TC AUTOMATIC PERSONALITY MODULE (APM) SWITCHBOX GXD EPT/A DIVISION OF BSC 821T APM 75485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other 09/06/2000 (STOP'D)) 4. CORDIS CONNECTION CABLE| 3. BIOSENSE (CORDIS/WEBSTER) CATHETER (09/06/00 TO| RECORDING SYSTEM (09/06/00 TO 09/06/00 (STOP'D))| (09/06/2000 TO 09/06/2000 (STOP'D)) 5. BIOSENSE| (STOP'D)).| 1. EPT-1000 TC CARDIAC ABLATION CONTROLLER,| JUNCTION BOX (09/06/2000 TO 09/06/2000 (STOP'D))| (09/06/00 TO 09/06/00 (STOP'D)), 2. PRUCKA| 6. PRUCKA JUNCTION BOX (09/06/2000 TO 09/06/2000