BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND STRAPSTAND

    MDR report key: 5286250 · Received December 10, 2015

    Report

    Report Number
    2183634-2015-00006
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 12, 2015
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STANDING FRAME IS JUST OVER 4 YEARS OLD AND WAS A REPRESENTATIVE SAMPLE, THEREFORE IT IS ASSUMED THE UNIT WAS USED QUITE FREQUENTLY. THE STRAP FROM THIS ISSUE WAS RETURNED AND VISUALLY INSPECTED. UPON INSPECTION IS WAS DETERMINED THAT THIS STRAP FAILED BECAUSE THE STRAP WAS NOT SEWN ALL THE WAY INTO THE REINFORCED STITCHES ON THE STRAP. THE SALES REPRESENTATIVE REQUESTED AN EXTRA-LARGE ADJUSTABLE SEAT STRAP AS THE REPLACEMENT STRAP FOR THIS UNIT AND THE REPLACEMENT STRAP WAS SHIPPED BY ALTIMATE MEDICAL TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    RECEIVED AN EMAIL FROM (B)(6), AN AMI INDEPENDENT REP, THAT THE LARGE ADJUSTABLE SEAT STRAP ON HIS STRAPSTAND SAMPLE UNIT HAD FAILED AND THAT HE NEEDED A REPLACEMENT STRAP. THE FACILITY THAT WAS USING THE STRAPSTAND AT THE TIME HAD A USER THAT WAS APPROXIMATELY (B)(6) LBS. AND WAS ABOUT 45 DEGREES FROM SITTING TO STANDING WHEN ONE SIDE OF THE STRAP TORE AWAY FROM THE BODY OF THE SEAT STRAP. THE USER HAD BEEN SITTING ON A HIGH-LOW MAT (GYM MAT), THEREFORE WHEN THE STRAP TORE AWAY THE USER WAS SUPPORTED BY THE MAT UNDERNEATH THEM. NO INJURIES TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816348 EASYSTAND STRAPSTAND STANDING FRAME ION ALTIMATE MEDICAL, INC. STRAPSTAND N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other