BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WAY, INC.

    MDR report key: 862866 · Received October 6, 2006

    Report

    Report Number
    2183887-2006-00002
    Event Type
    Malfunction
    Date Received
    October 6, 2006
    Date of Event
    September 11, 2006
    Report Date
    October 6, 2006
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A RESIDENT WAS BEING RAISED BY AN EZ LIFT FROM A BED WHEN A SCREW BROKE, AND THE RESIDENT WAS LOWERED BACK ONTO THE BED. NO INJURY OCCURRED, AND THE FACILITY CALLED EZ WAY FOR REPAIR PARTS. EZ WAY HAD PREVIOUSLY SENT REPLACEMENT PARTS TO THE FACILITY BUT THE REPLACEMENT WAS NEVER COMPLETED, ALTHOUGH THE FACILITY HAD SENT EZ WAY PAPERWORK STATING THAT THE REPLACEMENT HAD BEEN COMPLETED. THE LIFT HAD NOT BEEN MAINTAINED AS INSTRUCTED IN THE EZ WAY MAINTENANCE CHECKLIST, STATING THE NEED TO INSPECT AND TIGHTEN ALL BOLTS, AND HAD NOT BEEN UPGRADED PER THE PREVIOUS ASSEMBLY CHANGE REQUEST. ADDITIONAL REPLACEMENT PARTS WERE SENT TO THE FACILITY AND AN EZ WAY REP WENT TO THE FACILITY TO CONFIRM THE REPLACEMENT WAS COMPLETED AND INSPECT THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ WAY, INC. PATIENT LIFT FSA EZ WAY, INC. 798 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other