BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFINIUM 8000

    MDR report key: 2013553 · Received February 3, 2011

    Report

    Report Number
    2126677-2011-00007
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 3, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K051967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT BARRIER ROTATIONAL HANDLE LOCK WAS NOT HOLDING ON THE IMAGE PASTE STAND. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFINIUM 8000 X-RAY SYSTEM, STATIONARY KPR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1