BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROMEDIC EVA400EE

    MDR report key: 3159143 · Received June 3, 2013

    Report

    Report Number
    3005536958-2013-00033
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    January 23, 2013
    Report Date
    June 3, 2013
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO EMPLOYEES WERE TRANSFERRING A MALE RESIDENT TO A BED USING A PT LIFTING DEVICE. EMPLOYEE 1 WAS GUIDING AND POSITIONING THE RESIDENT WHILE EMPLOYEE 2 WAS PUSHING THE LIFT INTO POSITION, SLIDING THE LIFT LEGS UNDER THE BED. DURING THE TRANSFER, THE LIFT TIPPED FORWARD AND FELL ONTO EMPLOYEE 1, DROPPING THE RESIDENT ONTO THE BED. THE RESIDENT SUSTAINED NO INJURIES BUT EMPLOYEE 1 SUSTAINED A CONTUSION TO THE LEFT SIDE OF HER HEAD, A CONCUSSION, MULTIPLE ABRASIONS AND TWISTED HER BACK. THE LIFT WAS REMOVED FROM THE FLOOR AND TAKEN TO THE FACILITIES MAINTENANCE FOR INSPECTION. THE FACILITIES MAINTENANCE INSPECTED THE UNIT, NO DAMAGE WAS EVIDENT. IT WAS NOTED THAT A SCREW ATTACHING THE LEG SPREAD MECHANISM WAS FOUND TO BE LOOSE. THE FACILITIES MAINTENANCE ORDERED AND REPLACED THE SCREW. THE LIFT WAS RETURNED TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243486 ROMEDIC EVA400EE FSA HANDICARE AB EVA400EE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization