BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING

    MDR report key: 1945950 · Received December 17, 2010

    Report

    Report Number
    8030916-2010-00061
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.

    Description of Event or Problem · 1

    TWO CNAS WERE LIFTING THE RESIDENT OUT OF BED TO TRANSFER TO A CHAIR USING THE VIKING M - THEY WERE APPROACHING THE CHAIR FROM THE SIDE WHEN THE LIFT STARTED TO TIP WHILE UNDERNEATH THE CHAIR - THE CASTERS CAME OFF THE FLOOR AND THEY WERE SLIGHTLY INJURED WHILE TRYING TO PREVENT THE SLING BAR FROM HITTING THE RESIDENT. CNA #1 ALLEGED A LONG SCRATCH ON HER SHIN. CNA #2 ALLEGED THAT THE SLING BAR HIT HER IN THE TEMPLE AREA WHICH CAUSED A SLIGHT BRUISE. RESIDENT WAS NOT INJURED. THEY TRIED TO RE-CREATE THE SCENE AND THE ONLY WAY THEY WERE ABLE TO GET THE LIFT TO TIP WAS TO NOT FULLY EXTEND THE LEGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1