BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BISTIM

    MDR report key: 275297 · Received April 4, 2000

    Report

    Report Number
    8021774-2000-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2000
    Report Date
    March 24, 2000
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO IS WRITING TO DRAW YOUR IMMEDIATE ATTENTION TO A POSSIBLE ELECTRIC SHOCK HAZARD WHICH HAS BEEN IDENTIFIED FOR THE BISTIM MODULE WHEN USED WITH TWO MAGSTIM MODEL 200 UNITS. THE HAZARD IS NOT PRESENT WHEN THE BISTIM MODULE AND THE MODEL 200S ARE CONNECTED AS INTENDED AND AS DETAILED ON THE OPERATOR'S MANUAL. THIS HAZARD HAS BEEN IDENTIFIED ONLY DURING ROUTINE TESTING HERE AND THERE ARE NO REPORTS OF IT EVER HAVING OCCURRED DURING USE OF THE INSTRUMENT BY ANY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BISTIM COMBINES TWO MAGNETIC NERVE STIMULATORS ETN THE MAGSTIM COMPANY LTD. 9830-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *