BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EUREKA COLLIMATOR

    MDR report key: 2138105 · Received June 23, 2011

    Report

    Report Number
    1423380-2011-00002
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    IZW
    PMA / PMN Number
    K810598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    AN ONSITE TECHNICIAN FROM THE END USER REPORTED THAT THE MECHANICAL STRUCTURE OF A LINEAR IV COLLIMATOR UNIT, SERIAL NUMBER (B)(4), SEPARATED FROM ITS MOUNT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUREKA COLLIMATOR COLLIMATOR, AUTOMATIC, RADIOGRAPHIC IZW MIDMARK CORPORATION LINEAR IV

    Patients

    Seq Age Sex Outcome Treatment
    1