BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSARAD

    MDR report key: 599731 · Received April 27, 2005

    Report

    Report Number
    1418957-2005-00006
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    September 8, 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 HAS NOTIFIED FISCHER IMAGING OF FIVE (5) LEAKING TANKS INSTALLED IN THE VERSARAD GENERATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSARAD GENERAL RADIOGRAPHIC SYSTEM IZO FISCHER IMAGING CORP. 105307G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *