BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-EVOLUTION SYSTEM /FF WAL STAND

    MDR report key: 2550321 · Received April 19, 2012

    Report

    Report Number
    1317307-2012-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 14, 2012
    Report Date
    April 19, 2012
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K091889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POSITIONING OF THE WALL STAND USING MOTORIZED MOVEMENT SHOULD NOT BE COMPLETED WITH THE PT STANDING BY THE BUCKY OR LEANING ON THE LATERAL ARM SUPPORT OF THE BUCKY ACCORDING TO THE DRX EVOLUTION USER INSTRUCTIONS. CAUTION STATEMENTS IN THE USER GUIDE #9G5640 STATE: "WITH AUTO TRACKING ENABLED THE AUTOMATIC MOVEMENT APPROXIMATELY FOLLOWS THE OTC AND THE BUCKY. NO INDIVIDUALS OR OBJECTS SHOULD BE NEAR OR ON THE WALL STAND. IMPEDING THE MOTION OF THE OTC OR ADDING WEIGHT TO THE WALL STAND CAN CAUSE DAMAGE. OBSERVE THE PT AT ALL TIMES ESPECIALLY WHEN USING AUTOMATIC MOTION. THE ARM SUPPORT IS NOT DESIGNED TO BEAR A PT'S WEIGHT. IT IS INTENDED TO BE USED AS AN OVERHEAD HAND GRIP, POSITIONING THE ARMS OF THE PT WHILE THE X-RAY IS TAKEN. MAKE SURE THE EQUIPMENT DOES NOT COME INTO CONTACT WITH THE PT WHEN USING AUTOMATIC MOTION." SERVICE ENGINEERING REPAIRED THE ISSUE AT THE CUSTOMER SITE AND THERE HAVE NOT BEEN ANY FURTHER ISSUES WITH THE OPERATION OF THE EQUIPMENT. A CONFIRMED ROOT CAUSE HAS NOT BEEN IDENTIFIED, HOWEVER BASED UPON THE INVESTIGATION IT IS BELIEVED THAT THE RJ45 TYPE 1 CONNECTOR ON THE ONE END OF THE COMMUNICATION CABLE MAY HAVE HAD CRIMPED WIRES WITHIN THE CONNECTOR LEADING TO INTERMITTENT COMMUNICATION PROBLEMS. THE TMC BOARD, LEFT KEYPAD, AND LEFT AND RIGHT CABLES WERE REPLACED ON THE WALL STAND.

    Description of Event or Problem · 1

    CUSTOMER SITE REPORTS 2 ISSUES THAT RELATE TO DOWNWARD MOVEMENT OF THE WALL STAND BUCKY. THERE WERE NO PT INJURIES OR ADVERSE EVENTS AS A RESULT OF THIS ISSUE. EACH ISSUE RELATED TO THE RADIOLOGY TECHNOLOGIST (RT) PREPARING TO COMPLETE A CHEST X-RAY AND PRESSED THE AUTO TRACKING BUTTON WHILE THE PT WAS EITHER LEANING OR HOLDING ONTO THE ARMS OF THE WALL STAND BUCKY. WHEN PRESSING THE DOWN BUTTON ON THE LEFT KEYPAD THE BUCKY BEGAN TO MOVE DOWNWARD STOPPING 2 INCHES FROM THE FLOOR. ONCE THE BUCKY DID STOP MOVING, THE WALL STAND MOVED BACK UP, MANUALLY IN ONE INSTANCE BECAUSE THE BUTTONS WOULD NOT WORK. ONCE THE RT PRESSED THE AUTO TRACKING BUTTON AGAIN THERE WERE NO OTHER MALFUNCTIONS FOR THE REMAINDER OF THE DAY AND THE RT CONTINUED TO USE THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESTREAM DRX-EVOLUTION SYSTEM /FF WAL STAND DRX-EVOLUTION WALL STAND KPR CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN