BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILIFT200

    MDR report key: 4017670 · Received August 12, 2014

    Report

    Report Number
    3005536958-2014-00009
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    HANDICARE AB
    Product Code
    FMR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FACILITY STAFF MEMBER WAS TRANSFERRING THE RESIDENT FROM A WHEELCHAIR TO A BED USING THE MINI LIFT 200. DURING THE TRANSFER, THE LIFT TIPPED, THE RESIDENT SUFFERED A C-6 FRACTURE AND LEFT HIP FRACTURE. A HANDICARE REP VISITED THE FACILITY TO ASSESS THE INCIDENT. AFTER ASSESSING THE STAFF MEMBER'S STATEMENT, AN ATTEMPT WAS MADE TO RE-CREATE THE INCIDENT AS DESCRIBED BY THE STAFF MEMBER. WHEN THE LIFT WAS POSITIONED BY THE BED, THE BASE OF THE LIFT WAS APPROXIMATELY 6-8" UNDER THE BED FRAME, MAKING IT IMPOSSIBLE TO TIP FROM THIS POSITION. THE HANDICARE REP THEN TRIED A 'WORST CASE SCENARIO', ATTEMPTING TO TIP THE LIFT AWAY FROM THE BED AND WITH THE CASTOR'S LOCKED AND WAS STILL UNABLE TO CAUSE THE UNIT TO TIP. IT WAS NOTED THAT THERE WAS DAMAGE TO THE LIFT WHICH WAS INCONSISTENT WITH THE INCIDENT DESCRIBED BY THE STAFF MEMBER OPERATING THE LIFT. THE UNIT WAS FULLY INSPECTED AND TESTED BY THE HANDICARE REP AND DEEMED FIT FOR USE. BASED ON THE INFO SUPPLIED, HANDICARE FEEL THAT THE INCIDENT OCCURRED DUE TO THE EQUIPMENT BEING USED IN A WAY NOT ADVISED OR DESCRIBED IN THE USER MANUAL. BY FOLLOWING THE DIRECTIONS IN THE USER MANUAL, THE INCIDENT COULD NOT BE RE-CREATED. HANDICARE'S EVALUATION IS IMPROPER USE OF EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478926 MINILIFT200 FMR HANDICARE AB 200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization