BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND STRAPSTAND

    MDR report key: 3856174 · Received April 25, 2014

    Report

    Report Number
    2183634-2014-00002
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADJUSTABLE SEAT STRAP WAS RETURNED TO ALTIMATE AND REVIEWED. UPON REVIEW, IT WAS NOTED THAT THE INSERTED STRAP IN THE SEAT MISSED THE LAST ROW OF STITCHING. THIS APPEARS TO HAVE BEEN CAUSED BY INCONSISTENT MANUFACTURING PROCESSES AT THE SUPPLIER WHO MANUFACTURES THESE STRAPS. ALTIMATE MEDICAL HAS UPDATED THE PRODUCT SPECIFICATIONS TO ADD ADD'L DETAILED INFO TO THE PRODUCT SPECIFICATIONS FOR THIS COMPONENT AND HAS COMMUNICATED WITH THE SUPPLIER REGARDING THEIR QUALITY CONTROL PROCESS. ALTIMATE HAS ALSO IMPLEMENTED A RECEIVING INSPECTION PROCESS ON THIS COMPONENT IN ADDITION TO THE CURRENT INSPECTION PROCESS PERFORMED DURING THE ASSEMBLY AND SHIPPING PROCESS.

    Description of Event or Problem · 1

    RECEIVED A CALL FROM A WOMAN WHO PURCHASED A STRAPSTAND IN (B)(6) 2012 FOR HER HUSBAND. SHE SAID HER AND A HELPER WERE PUTTING HIM IN THE UNIT WHEN ONE SIDE OF THE STRAP TORE AWAY FROM THE PADDED SEAT BODY OF THE XL ADJUSTABLE SEAT STRAP ON AN EASYSTAND STRAPSTAND. THE USER WAS NOT INJURED BUT STARTLED WHEN IT OCCURRED. BOTH OF THEM WERE ON EACH SIDE OF HIM AND HE FELL BACK INTO HIS WHEELCHAIR, WHICH IS POSITIONED UP TO THE STANDING FRAME, SO IT'S AVAILABLE WHEN THE USER GOES BACK TO THE SEATED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252306 EASYSTAND STRAPSTAND 890.5370 ION ALTIMATE MEDICAL, INC. STRAPSTAND NA

    Patients

    Seq Age Sex Outcome Treatment
    1