BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STAND

    MDR report key: 790393 · Received November 21, 2006

    Report

    Report Number
    2183887-2006-00003
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Date of Event
    October 21, 2006
    Report Date
    November 21, 2006
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE EZ STAND TO RAISE A RESIDENT FROM A CHAIR, THE MAST OF AN 11 YEAR-OLD UNIT SEPARATED FROM THE BASE, TIPPING THE UNIT FORWARD AND LOWERING THE RESIDENT BACK ONTO A CHAIR. NO INJURY OCCURRED AS A RESULT OF THE INCIDENT. AN EZ WAY SALES PERSON WENT TO THE FACILITY TO INVESTIGATE THE ISSUE AND EXAMINE THE EQUIPMENT. THE UNIT WAS ONE OF THE EARLIEST UNITS MANUFACTURED BY THE COMPANY, AND THE BASE WELD HAD BEEN SANDED TO CREATE A SMOOTH SURFACE. THE SANDING COMPROMISED THE STRENGTH OF THE WELD, AND COMBINED WITH USAGE OVER THE 11-YEAR PERIOD CREATED A WEAK POINT IN THE BASE. PER THE COMPANY'S PRODUCTION NOTES AND PRINTS, THIS PROCESS WAS CHANGED SHORTLY AFTER THE INITIAL PRODUCTION RUN OF UNITS. EZ WAY CONTACTED ALL OWNERS OF UNITS WITH A SERIAL NUMBERS MANUFACTURED PRIOR TO THE PRINT CHANGE, PROVIDED PRODUCT INSPECTION DIRECTIONS, AND IDENTIFIED 4 ADD'L UNITS MANUFACTURED IN THE SAME MANNER. FOUR UNITS WERE REMOVED FROM THE FIELD AND REPLACED, AND ONE WAS REPAIRED. NO ADD'L UNITS MANUFACTURED WITH THE WELD SMOOTHING PROCESS REMAIN IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STAND PATIENT LIFT FSA EZ WAY, INC. 894 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN