BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSHIBA

    MDR report key: 178556 · Received July 16, 1998

    Report

    Report Number
    178556
    Event Type
    Malfunction
    Date Received
    July 16, 1998
    Date of Event
    June 30, 1998
    Report Date
    July 15, 1998
    Manufacturer
    TOSHIBA AMERICAN MEDICAL SYSTEMS
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SYSTEM SHUT DOWN DURING PROCEDURE. OVERLOAD LIT UP, UNABLE TO CINE FOR 15 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA GENERATOR IZO TOSHIBA AMERICAN MEDICAL SYSTEMS KXO-200A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other