BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-EVOLUTION FULL FEATURED WALL ST

    MDR report key: 3243169 · Received July 18, 2013

    Report

    Report Number
    1317307-2013-00010
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 18, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K091889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE FIELD ENGINEER (FE) REPORT, THE WALL STAND (WS) CONTROL BUTTON WAS REPLACED A FEW WEEKS AGO. HOWEVER, THE FE REPLACED THE KEYPAD, COMPLETED FURTHER EVALUATION OF THE KEYPAD BUTTONS TO MAKE SURE THEY WERE NOT STICKING AND CHECKED THE Z-AXIS DRIVE MECHANISM. THE REPLACED KEYPAD WAS SENT BACK TO CARESTREAM IN ROCHESTER, NY FOR ANALYSIS. A ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED FOR THIS ISSUE. THE FAILURE IS RELATED TO FRACTURED SOLDER JOINTS LOCATED BETWEEN COMPONENT LEG AND SOLDER PAD ON THE MAIN CIRCUIT BOARD OF THE WS KEYPAD. THESE FRACTURES WERE CAUSED BY THE FORCE OF BUTTON PUSHES DIRECTLY ON THE MAIN CIRCUIT BOARD OF THE KEYPAD. CARESTREAM PLANS TO TAKE CORRECTIVE ACTION TO RESOLVE THIS ISSUE AND REPORT THIS IN A PLAN OF CORRECTIONS AND REMOVALS TO THE FDA.

    Description of Event or Problem · 1

    THE RADIOLOGY TECHNOLOGIST (RT) WAS USING AUTO-TRACKING AT THE WALL STAND (WS). THE RT PRESSED THE KEYPAD BUTTON TO MOVE THE WS DOWN, AND THE WS BUCKY MOVED DOWN TO THE FLOOR WITH THE TUBE TRACKING WITH THE WS BUCKY. THE RT RELEASED THE BUTTON, BUT THE WS BUCKY CONTINUED TO MOVE DOWN TO THE FLOOR. THE PATIENT WAS HOLDING ON TO THE PATIENT BAR DURING THE EVENT, HOWEVER THE RT MOVED THE PATIENT AWAY FROM THE WS AND THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335407 CARESTREAM DRX-EVOLUTION FULL FEATURED WALL ST DRX-EVOLUTION FF (FULL FEATURED) WS (WALLST KPR CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA