BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFINIUM 8000

    MDR report key: 2313558 · Received October 3, 2011

    Report

    Report Number
    2126677-2011-00135
    Event Type
    Malfunction
    Date Received
    October 3, 2011
    Date of Event
    August 15, 2011
    Report Date
    October 3, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K051967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITH IN THE LAST TWO YEARS. REFERENCE MDR 212667-2010-00010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT BARRIER ROTATIONAL HANDLE LOCK WAS BROKEN IN A MANNER THAT PREVENTED IT FROM LOCKING INTO POSITION. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1