BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW DR 7500 SYSTEM

    MDR report key: 2116788 · Received June 1, 2011

    Report

    Report Number
    1317307-2011-00002
    Event Type
    Other
    Date Received
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K051258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TRAINING FOR THE KODAK DIRECTVIEW DR 7500 SYSTEM EMPHASIZES THAT THE BUCKY AND WALL STAND ARE NOT TO BE USED FOR PT SUPPORT. THE "KODAK DIRECTVIEW DR 7500 SYSTEM AND CARESTREAM DR LONG LENGTH IMAGING SYSTEM SAFETY AND REGULATORY GUIDE" (B)(4) CONTAINS SAFETY INFO RELATING TO THE WALL STAND AND BUCKY AS FOLLOWS: "USE CAUTION WHEN ROTATING THE WALL STAND BUCKY. KEEP HANDS AND OTHER BODY PARTS AWAY FROM MOVING PARTS.' "KEEP THE PT AWAY FROM THE BUCKY ASSEMBLY WHEN ROTATING THE BUCKY, OR WHEN MOVING IT HORIZONTALLY OR VERTICALLY." "CAUTION: THE WEIGHT LIMIT OF THE TABLE BUCKY IS 18 KG (40 LB). DO NOT EXCEED THIS WEIGHT ON THE BUCKY SURFACE."

    Description of Event or Problem · 1

    DURING A PT EXAM UTILIZING THE DR 7500 WALL STAND, THE PT BECAME UNSTABLE AND GRABBED ONTO THE WALL STAND BUCKY FOR SUPPORT. THE WALL STAND BUCKY IS DESIGNED TO ROTATE 90 DEGREES BETWEEN PORTRAIT AND LANDSCAPE MODES WHEN THE REQUIRED AMOUNT OF ROTATIONAL FORCE IS APPLIED TO OVERCOME A DETENT. THE PT APPLIED ENOUGH FORCE TO OVERCOME THE DETENT WHEN HE OR SHE LEANED ON THE BUCKY FOR SUPPORT. THE BUCKY ROTATED AND THE PT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW DR 7500 SYSTEM DR 7500 KPR CARESTREAM HEALTH, INC. DR 7500

    Patients

    Seq Age Sex Outcome Treatment
    1