BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVA 450EE PATIENT LIFT

    MDR report key: 2317050 · Received October 28, 2011

    Report

    Report Number
    3005536958-2011-00002
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    October 6, 2011
    Report Date
    October 28, 2011
    Manufacturer
    HANDICARE, AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TRANSFER FROM WHEELCHAIR TO BED, CNA'S WERE PUSHING ON THE RESIDENT IN SLING FOR BETTER POSITIONING WHILE RESIDENT WAS OVER BED. THE LIFTS LEGS WERE STOPPED BY THE FRAME OF THE BED WHILE THE STAFF WAS PUSHING ON THE RESIDENT IN SLING. LIFT TIPPED AND PT FELL ONTO BED. NO REPORTED INJURY TO PT. COMPANY REP INSPECTED LIFT AND FOUND NOTHING WRONG WITH LIFT. COMPANY REP AND (B)(6) WERE ABLE TO SUCCESSFULLY REPLICATE INCIDENT AS DESCRIBED. IT WAS DETERMINED THE APPARENT CAUSE OF INCIDENT IS USER ERROR. STAFF MEMBERS WERE RE-TRAINED BY (B)(6) AND REP OF LIFT SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVA 450EE PATIENT LIFT PATIENT LIFT FSA HANDICARE, AB EVA 450EE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other