BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV

    MDR report key: 1407790 · Received June 25, 2009

    Report

    Report Number
    2183634-2009-00001
    Event Type
    Injury
    Date Received
    June 25, 2009
    Date of Event
    May 19, 2009
    Report Date
    June 25, 2009
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IN 2009: THE ORIGINAL CLAMP THAT WAS BROKEN WAS RETURNED TO ALTIMATE MEDICAL (AMI) ON MAY 26, 2009. AMI'S PRODUCT DEVELOPMENT MGR VISUALLY REVIEWED THE PART THAT WAS RETURNED AND PERFORMED AN INTERNAL EVAL ON THE SAME PART # TAKEN FROM OUR STOCK TO PERFORM AN EVAL AND ATTEMPT TO DUPLICATE THE PROBLEM. THE COMPONENT WAS ASSEMBLED INTO ITS TYPICAL CONFIGURATION AND TESTED IN TWO DIFFERENT MODES AS DESCRIBED BELOW. FIRST, THE RIGHT SIDE KNEE BRACKET THAT THIS COMPONENT IS USED TO CLAMP WAS EXTENDED TO ITS OUTERMOST SETTING, TO SIMULATE THE GREATEST LEVERAGE POSSIBLE, AND THE CLAMP HANDLE WAS TIGHTENED SECURELY, AS IT WOULD BE DURING NORMAL AND CORRECT USAGE. FORCE WAS APPLIED TO THE BRACKET IN A FORWARD AND OUTWARD MOTION, SO AS TO SIMULATE APPROXIMATE USAGE. FORCE WAS INCREASED TO A LEVEL WHICH BENT THE KNEE BRACKET TO ABOUT 70 DEGREES OUTWARD FROM ITS NORMAL POSITION. IT IS ESTIMATED THAT NEARLY 200 LBS OF FORCE WERE REQUIRED TO ACCOMPLISH THIS. NO DAMAGE OR FAILURE OCCURRED TO THE PLASTIC CLAMP. NEXT, THE ASSEMBLY WAS SET UP IN A LIKE MANNER TO THE FIRST TEST, BUT THE CLAMP LEVER WAS INTENTIONALLY LEFT LOOSE, SO THAT THE AMOUNT OF THREAD ENGAGING THE CLAMP WAS ONLY ABOUT 3/8 INCH. FORCE WAS ALSO APPLIED TO THE BRACKET, AS IN THE FIRST TEST. AT APPROXIMATELY 65 LBS OF APPLIED FORCE, THE THREAD BOSS PORTION OF THE PLASTIC CLAMP SEPARATED, ALLOWING THE BRACKET TO FALL AWAY FROM ITS SUPPORT. CONCLUSION: BASED ON THIS INFO, THE CONCLUSION WAS DRAWN THAT THE CLAMPING HANDLE WAS NOT TIGHTENED SECURELY AS IT SHOULD HAVE BEEN.

    Description of Event or Problem · 1

    THE END USER IS A HIGH LEVEL QUADRIPLEGIC, WHO USES A MOUTH STICK TO CONTROL HIS WHEELCHAIR. HE WAS USING AN EASYSTAND EVOLV WITH THE ASSISTANCE OF TWO ATTENDANTS WHEN THE CLAMP ON THE RIGHT SIDE KNEE SUPPORT BROKE CAUSING THE USER TO LOSE THE SUPPORT ON THEIR RIGHT KNEE. WHEN THIS OCCURRED THE USER HIT THEIR CHIN ON THE FRONT PAD OF THE TABLE ON THE EASYSTAND EVOLV. THE USER STATED THAT HE HAD PAIN IN HIS NECK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other