BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND STRAPSTAND

    MDR report key: 3633646 · Received December 18, 2013

    Report

    Report Number
    2183634-2013-00005
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THIS ISSUE THE CURRENT INVENTORY OF THE ADJUSTABLE STRAPS AT ALTIMATE MEDICAL WAS TESTED AT 1.5 TIMES THE MAXIMUM ADVERTISED USER WEIGHT LIMIT. 70 STRAPS WERE TESTED INTERNALLY AND OF OUT OF THOSE 70, 3 OF THE STRAPS HAD ONE SIDE WHERE THE STRAP TORE AWAY FROM THE MAIN SEAT BODY. THIS APPEARS TO HAVE BEEN CAUSED BY INCONSISTENT MANUFACTURING PROCESSES AT THE SUPPLIER WHO MANUFACTURES THESE STRAPS. ALTIMATE MEDICAL IS WORKING ON UPDATING AND ADDING ADDITIONAL INFORMATION TO THE PRODUCT SPECIFICATIONS FOR THIS COMPONENT AND IS COMMUNICATING WITH THE SUPPLIER REGARDING THEIR QUALITY CONTROL PROCESSES.

    Description of Event or Problem · 1

    RECEIVED AN EMAIL FROM OUR RUSSIAN DISTRIBUTOR THAT THE STRAP TORE AWAY FROM THE PADDED SEAT BODY OF THE LARGE ADJUSTABLE SEAT STRAP ON AN EASYSTAND STRAPSTAND. WE WERE ALSO INFORMED THAT WHEN THE STRAP FAILED THE SUER'S BROTHER CAUGHT HIM TO PREVENT THE USER FROM FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663793 EASYSTAND STRAPSTAND 890.5370 ION ALTIMATE MEDICAL, INC. STRAPSTAND NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other