BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTRIPSY TABLE

    MDR report key: 1041341 · Received April 24, 2008

    Report

    Report Number
    1041341
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDISPEC LTD
    Product Code
    LNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR ESWL (EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY) PROCEDURE. FIRST CASE WAS COMPLETED WITHOUT ANY INCIDENT AND THE BED WAS FULLY OPERATIONAL. IN THE BEGINNING OF THE SECOND CASE, THE PATIENT WAS SEDATED, AND POSITIONED PROPERLY, IT WAS THEN NOTICED THAT THE BED WOULD NOT OPERATE CORRECTLY. BIO-MED WAS NOTIFIED AND UNABLE TO FIX THE PROBLEM. PROCEDURE WAS CANCELED. SERVICE REP FROM MEDISPEC WAS IN TO FIX THE TABLE ON THAT EVENING. THE BED WAS UNABLE TO BE FIXED AT THAT TIME, SO THE COMPANY GAVE US A REPLACEMENT BED UNTIL OURS CAN BE PROPERLY FIXED.====================== MANUFACTURER RESPONSE FOR LITHOTRIPSY TABLE, LITHOTRIPSY TABLE======================NOT KNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOTRIPSY TABLE TABLE, LITHOTRIPSY LNS MEDISPEC LTD TT4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *