BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSARAD

    MDR report key: 598660 · Received April 27, 2005

    Report

    Report Number
    1418957-2005-00003
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    January 31, 2004
    Report Date
    April 27, 2005
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR NOTED TWO OF THE FOUR T NUTS ON THE TRANSVERSE BRIDGE ASSEMBLY WERE CRACKED. THE CRACKS WERE DISCOVERED ON ONE UNIT AT A USER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSARAD GENERAL RADIOGRAPHIC SYSTEM IZO FISCHER IMAGING CORP. DR 9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *