BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA FLOOR LIFT

    MDR report key: 8705990 · Received June 17, 2019

    Report

    Report Number
    3009481053-2019-00023
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 17, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    WHEN RESIDENT WAS TRANSFERRED FROM SHOWER TABLE TO CHAIR. THE LEG SUPPORT WAS UNABLE TO BE REMOVED SO THE STAFF NEEDED TO BRING THE LIFT INTO THE SIDE OF THE CHAIR. AS THEY WERE PULLING THE RESIDENT BACK INTO THE CHAIR THE LIFT TIPPED OVER, AND THE RESIDENT FELL TO THE CHAIR. THE LEG OF THE FLOOR LIFT HIT ONE STAFF AND THE AMST HIT ANOTHER STAFF ON SHOULDER. BOTH STAFF MEMBERS SAID THEY ARE FINE. THE RESIDENT WAS NOT INJURED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497390 EVA FLOOR LIFT PATIENT LIFT FSA HANDICARE AB 610233431

    Patients

    Seq Age Sex Outcome Treatment
    1