BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ LIFT

    MDR report key: 907744 · Received September 4, 2007

    Report

    Report Number
    2183887-2007-00001
    Event Type
    Malfunction
    Date Received
    September 4, 2007
    Date of Event
    August 4, 2007
    Report Date
    August 31, 2007
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A RESIDENT WAS BEING TRANSFERRED WITH A LIFT, WHEN THE LIFT HANGER CAME LOOSE, CAUSING THE RESIDENT TO SLIP TO THE FLOOR. THE RESIDENT WAS NOT INJURED. MAINTENANCE PERSONNEL CONTACTED EZ WAY TO REPORT THE INCIDENT. THE HANGER ASSEMBLY WAS SENT TO EZ WAY FOR INSPECTION, AND WAS FOUND TO HAVE EXTREMELY UNUSUAL WEAR NOT CONSISTENT WITH NORMAL USAGE OF THE UNIT, AND NEVER SEEN BEFORE BY THE COMPANY. THE LIFT WAS ORIGINALLY SOLD IN 1998. THE MAINTENANCE MANAGER STATED, THEY HAD NOT INSPECTED THE PARTICULAR WEAR POINTS AND ANY LOOSENESS AS INSTRUCTED IN THE EZ WAY MAINTENANCE CHECKLIST. AN EZ WAY REPRESENTATIVE WAS SENT TO THE FACILITY TO INVESTIGATE AND INSERVICED STAFF ON THE PROPER USAGE AND MAINTENANCE NECESSARY TO MAINTAIN EQUIPMENT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ LIFT PATIENT LIFT FNG EZ WAY, INC. 796 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR