BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2000 SYSTEM

    MDR report key: 48797 · Received October 4, 1996

    Report

    Report Number
    48797
    Event Type
    Malfunction
    Date Received
    October 4, 1996
    Date of Event
    September 26, 1996
    Report Date
    October 4, 1996
    Manufacturer
    BURKHART ROENTGEN INTL
    Product Code
    IWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAD SHIELD BROKE FROM ITS SUPPORT MOUNTED FROM THE CEILING AND FELL TOWARDS THE FLOOR. THE OPERATOR OF THE SHIELD WAS HOLDING IT WHEN IT BROKE AWAY FROM THE SUPPORT. THE PT WAS NOT INJURED. PER MFR PROTECTIVE SHIELD FELL-WELD BROKE. UPON INSPECTION OF THE RETURNED WINDOW FRAME, IT WAS DISCOVERED THAT THERE WAS DAMAGE TO THE WELDED PIVOT FROM SOME PREVIOUS IMPACT. A SAFETY CABLE WAS INSTALLED INSIDE THE PIVOT AND THE PIVOT WAS RE-WELDED AND RE-ENFORCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2000 SYSTEM PROTECTION SHIELD IWQ BURKHART ROENTGEN INTL 087-815264 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other