BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO

    MDR report key: 2083382 · Received April 28, 2011

    Report

    Report Number
    8030916-2011-00024
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 29, 2011
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR INSPECTED THE LIFT AND FOUND IT FUNCTIONING AS DESIGNED. HE COULD NOT DUPLICATE THE EVENT. THE LIFT IS BACK IN USE. THE DISTRIBUTOR INSTRUCTED STAFF ON THE PROPER LIFTING PROCEDURES.

    Description of Event or Problem · 1

    THE NURSING HOME STAFF ALLEGED THAT WHILE MOVING A RESIDENT FROM A BED TO A WHEELCHAIR, THEY TURNED THE RESIDENT AND REPOSITIONED HER LEGS TO SET HER IN CHAIR AND THE LIFT TIPPED OVER TO THE LEFT SIDE. THE STAFF ALLEGED THE LEGS WERE PROPERLY SET ON LIFT. THE STAFF STATED THE PATIENT HAD STIFF LEGS AND THE STAFF HAD TO POSITION HER LEGS ONE ON EACH SIDE OF THE MAST. ONE STAFF MEMBER WAS POSITIONED BEHIND THE LIFT AND ANOTHER POSITIONED ON THE RIGHT SIDE WITH HANDS ON THE RESIDENT. THE RESIDENT FELL ON THE NURSE AID. THE RESIDENT BUMPED HER RIGHT UPPER FOREHEAD AND OBTAINED A PARTIAL SKIN TEAR/ABRASION ON HER LEFT ARM. THE NURSE AID COMPLAINED OF BACK PAIN, WAS CHECKED OUT IN THE ER AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO NON AC POWERED PATIENT LIFT FSA LIKO AB UNO 100EM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK