BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-EVOLUTION FULL FEATURED WALL ST

    MDR report key: 3243171 · Received July 18, 2013

    Report

    Report Number
    1317307-2013-00011
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 27, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION AT THE CUSTOMER SITE THE FIELD ENGINEER (FE) NOTED THAT THE MOVEMENT STOPS IF THE KEYPAD BUTTON IS PRESSED ONE TIME AND/ OR MULTIPLE TIMES. IT WAS ALSO DETERMINED THAT THE WS MAY NOT START MOVING WHEN THE BUTTON WAS PRESSED ONE TIME, AND MAY REQUIRE MULTIPLE BUTTON PRESSES. THE FE REPLACED THE KEYPAD AT THIS SITE. 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 SITE REPORTED THE WS WOULD NOT STOP MOVING DOWNWARD WHEN THE RADIOLOGY TECHNOLOGIST (RT) RELEASED THE KEYPAD MOVEMENT BUTTON. THERE WAS NO INJURY TO THE USER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335335 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