BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTRIPSY UNIT SW-7 MEDSPEC

    MDR report key: 1417047 · Received June 29, 2009

    Report

    Report Number
    1417047
    Event Type
    Malfunction
    Date Received
    June 29, 2009
    Date of Event
    June 23, 2009
    Report Date
    June 29, 2009
    Manufacturer
    MEDISPEC LTD
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWAL) MALFUNCTIONED. TROUBLESHOOTING DONE BY STAFF AND BIOMED. LITHOTRIPER MISFIRED. STAFF REMOVED SPARK PLUG; NO DAMAGE. CHANGED WATER. WITHIN TEN SHOTS, THE MALFUNCTION HAPPENED AGAIN. CALL MEDISPEC, AND TRIGGER CHANGED FOR ECG TO SLOW. PROBLEM STILL EXISTED. KV OUTPUT TO 15. MISFIRED, BUT NOT AT THE SAME FREQUENCY. MD WAS ABLE TO GET THROUGH THE CASE. THE REP FROM MEDISPEC CAME IN TO COMPLETE REPAIR. HE REPLACED THE HIGH VOLTAGE GENERATOR. IT SHOULD BE REPLACED EVERY 1 MILLION SHOTS. METER READ 1,699,000 AND WAS OVERDUE. HE ALSO REPLACED THE MEMBRANE. NOW FULLY OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOTRIPSY UNIT SW-7 MEDSPEC LITHOTRIPTER, ULTRASONIC FFK MEDISPEC LTD 16-230A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *