BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFINIUM 8000

    MDR report key: 3810794 · Received March 21, 2014

    Report

    Report Number
    2126677-2014-00005
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K051967
    Removal / Correction Number
    2126677-10/5/11-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS NOT DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST THREE YRS. REFERENCE MDR 2126677-2010-00010. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806 ON 10/05/2011. REFERENCE CORRECTIONS AND REMOVALS REPORT NUMBER 2126677-10/5/11-002-C. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169665 DEFINIUM 8000 STATIONARY X-RAY SYSTEM KPR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1