BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFINIUM 8000

    MDR report key: 2020620 · Received February 10, 2011

    Report

    Report Number
    2126677-2011-00014
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 10, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K051967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS DISCOVERED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS RELATED TO A KNOWN ISSUE THAT RESULTED IN THE EVENT REPORTED IN MDR 2126677-2010-00010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT BARRIER ROTATIONAL HANDLE LOCKS WERE BROKEN. 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