BEUDAMED
    FDA Adverse Event Summary report: N

    TRIXIE

    MDR report key: 3110534 · Received April 8, 2013

    Report

    Report Number
    1419652-2013-00088
    Date Received
    April 8, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED IN A TRIXIE LIFT, A LIFTER FOR ASSISTED MOVING, AND AS REPORTED FROM THE CUSTOMER THE C N A WAS MOVING THE RESIDENT FROM THE WHEELCHAIR TO HIS BED WHEN THE GREY CLIP ON THE SLING CRACKED DOWN THE MIDDLE CAUSING THE CLIP TO UNCLIP FROM THE LIFT. THE RESIDENT FELL HITTING HIS FOOT ON THE LOWER PART OF THE LIFT. AN ARJOHUNTLEIGH TECHNICIAN HAS VISITED THE SITE AND INSPECTED THE DEVICE AND FOUND THE DEVICE TO BE IN A GOOD CONDITION. THE SLING THAT WAS USED WAS WORN AND THE CLIP HAD JUST SPLIT DOWN THE MIDDLE AND THEN DETACHED FROM THE LIFT. MFR REF NUMBER 9611530-2013-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144327 TRIXIE PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD KTA0200

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR