BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND STRAPSTAND

    MDR report key: 3748051 · Received January 24, 2014

    Report

    Report Number
    2183634-2014-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER DISCUSSING THIS ISSUE FURTHER WITH THE FACILITY, IT WAS DETERMINED THAT THIS FACILITY HAS HAD THE STANDING FRAME FOR APPROXIMATELY 7 YEARS AND USES THE DEVICE ON A DAILY BASIS WITH 10 DIFFERENT RESIDENTS. IT IS ASSUMED THAT THE STITCHING CAME LOOSE ON THIS STRAP DUE TO AMOUNT OF TIME THAT THIS PRODUCT HAS BEEN USED. THE FACILITY STATED THAT OVERALL THE PRODUCT IS IN GOOD CONDITION AND THAT THEY WOULD LIKE TWO REPLACEMENT STRAPS DUE TO THE AMOUNT THAT THIS PRODUCT IS USED. ALTIMATE PROVIDED THE FACILITY WITH TWO REPLACEMENT STRAPS PER THEIR REQUEST.

    Description of Event or Problem · 1

    RECEIVED A CALL FROM A FACILITY THAT THE STITCHING CAME LOOSE ON THE LARGE STRAP, PART NO. 80719 ON THEIR EASYSTAND STRAPSTAND STANDING FRAME. THE FACILITY HAS HAD THE UNIT SINCE (B)(6) 2007 AND THEY USE THE UNIT EVERY DAY WITH APPROXIMATELY 10 DIFFERENT RESIDENTS. THE USER'S WHEELCHAIR IS POSITIONED UP TO THE STANDING FRAME SO IT'S AVAILABLE WHEN THE USER GOES BACK TO THE SEATED POSITION, THEREFORE, NO INJURIES WERE REPORTED WHEN THE STITCHING CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56062 EASYSTAND STRAPSTAND 890.5370 ION ALTIMATE MEDICAL, INC. STRAPSTAND NA

    Patients

    Seq Age Sex Outcome Treatment
    1