BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFINIUM 8000

    MDR report key: 2449849 · Received February 2, 2012

    Report

    Report Number
    2126677-2012-00015
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    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
    SC, US
    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 WITHIN THE LAST TWO YEARS. REFERENCE MDR 2126677-2010-00010. INITIAL REPORTER OCCUPATION WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION CONCLUDED THAT THE MECHANISM WHICH APPLIES FRICTION TO THE DEFINIUM 8000 PT BARRIER PIVOTING ARM WEARS RAPIDLY ALLOWING THE ARM TO SWING FREELY WHEN THE LOCK IS NOT APPLIED. THE RESULT IS THAT THE PIVOTING ARM MAY BE STORED IN AN UPRIGHT POSITION WHICH WILL BE UNSTABLE DUE TO A LACK OF RESIDUAL FRICTION. GE HEALTHCARE WILL MODIFY THE ROTATING ARMS TO RESTORE THE RESIDUAL FRICTION SO THAT THE ARM WILL RETAIN POSITION (RATHER THAN SWING FREELY) WHILE THE LOCKING LEVERS ARE DISENGAGED. THE PRODUCT LABELING WILL ALSO BE UPDATED TO IMPROVE AWARENESS AND IDENTIFY THE HAZARD RELATIVE TO PROPER STORAGE. THIS ACTION HAS BEEN REPORTED TO FDA PER 21 CFR PART 806 ON (B)(4) 2011. REFERENCE CORRECTIONS AND REMOVALS REPORT NUMBER (B)(4).

    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
    1 DEFINIUM 8000 STATIONARY X-RAY SYSTEM KPR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1