BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 1593144 · Received February 1, 2010

    Report

    Report Number
    2183634-2010-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 26, 2010
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG NUMBER: PNG50024. JANUARY 27, 2010. EVAL SUMMARY: THE ORIGINAL EASYSTAND EVOLV GLIDER WAS RETURNED TO ALTIMATE MEDICAL ON JANUARY 25, 2010. UPON REVIEW, THE ACTUAL CAUSE OF WHY THE CASTER BROKE OFF THIS UNIT COULD NOT BE DETERMINED. IT CAN BE SPECULATED THAT THE FOLLOWING MAY HAVE OCCURRED WHICH CAUSED THIS TO HAPPEN: THE UNIT MAY HAVE BEEN DROPPED WHEN BEING DELIVERED WHICH CAUSED THE CASTER TO BEND AND WITH USE OVER TIME CAUSED THIS CASTER TO BREAK. BASED ON REVIEW OF THE EVOLV BASE, THE AREA WHERE THE CASTER THREADS INTO LOOKS TO BE DAMAGED AND THERE IS PAINT SCRAPED OFF OF THE BASE IN THAT AREA. THE CASTER MAY HAVE LOOSENED OVER TIME CAUSING THE CASTER TO BACK OUT OF THE BASE WHICH MAY HAVE CAUSED THIS TO OCCUR. THE CASTER MAY HAVE BEEN DAMAGED WHEN MOVING THE UNIT, EITHER BY RUNNING INTO A WALL OR BY GOING OVER A THRESHOLD. THE BASE SHOWING DAMAGE COULD ALSO BE A FACTOR IN THIS SCENARIO. WE HAVE BEEN IN CONTACT WITH THE CASTER SUPPLIER, AND THEY WILL BE REVIEWING THE CASTER AS WELL TO SEE IF THEY CAN PROVIDE US WITH ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    A USER WAS SITTING IN AN EASYSTAND EVOLV GLIDER ABOUT HALF WAY UP TO THE STANDING POSITION WHEN ONE OF THE REAR CASTERS BROKE OFF THE UNIT. THE USER'S ATTENDANT WAS NEXT TO HIM AND SUPPORTED THE EASYSTAND, THEREFORE, THE USER WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND EVOLV 890.3110 INO ALTIMATE MEDICAL, INC. EVOLV ADULT GLIDER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other