BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND BANTAM

    MDR report key: 1575266 · Received December 9, 2009

    Report

    Report Number
    2183634-2009-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2009
    Date of Event
    November 12, 2009
    Report Date
    December 2, 2009
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K091242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEC 2, 2009. THE ORIGINAL EASYSTAND BANTAM XS WAS RETURNED TO ALTIMATE MEDICAL ON NOV 24, 2009. UPON REVIEW OF THE UNIT, IT WAS CONFIRMED THAT A WELD WAS MISSING ON A BRACKET THAT PROVIDES A MOUNTING POINT FOR THE LINK CONNECTING THE FOOTREST AND KNEE HOLDER ASSEMBLY TO THE BACK BRACKET. THE ABSENCE OF THE WELD ALLOWED PRESSURE FROM THE BACK BRACKET ASSEMBLY, WHICH ALSO CONTAINS THE TRAY MOUNTING ASSEMBLY TO DISPLACE THE BRACKET FROM ITS PROPER POSITION AND EXCEED THE MECHANICAL STRENGTH OF THE BRACKET, THEREBY CAUSING IT BREAK OFF AND ALLOWING THE TRAY/BACK COMBINATION TO FALL FORWARD. THE DESIGN STRENGTH LIES IN THE PRESENCE OF BOTH WELDS DUE TO THE "FORKED" NATURE OF THE BRACKET, IN WHICH IT ENCIRCLES 3 SIDES OF A SQUARE TUBE.

    Description of Event or Problem · 1

    A CHILD WAS USING AN EASYSTAND BANTAM XS (EXTRA SMALL) WHEN THE BRACKET THAT PROVIDES A MOUNTING POINT FOR THE LINK CONNECTING THE FOOTREST AND KNEE HOLDER ASSEMBLY TO THE BACK BRACKET, FAILED CAUSING THE TRAY/BACK COMBINATION TO FALL FORWARD. THE CHILD WAS NOT INJURED DUE TO THE FACT THAT TWO ATTENDANTS WERE NEARBY TO SUPPORT HER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other