BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIKING

    MDR report key: 613477 · Received June 6, 2005

    Report

    Report Number
    1225750-2005-00009
    Event Type
    Other
    Date Received
    June 6, 2005
    Date of Event
    May 6, 2005
    Report Date
    June 3, 2005
    Manufacturer
    LIKE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005, A PT FELL WHILE BEING RAISED IN A VIKING M PT LIFT/HOIST. ACCORDING TO THE FACILITY, THE PT WAS BEING LIFTED FROM A WHEELCHAIR WHEN THE SLING HANGER BAR'S ADAPTER BROKE. THIS CAUSED THE PT TO FALL APPROX 3 INCHES BACK INTO THE WHEELCHAIR. THE PT REPORTEDLY WAS NOT INJURED. THE EQUIPMENT WAS TAKEN OUT OF SERVICE UNTIL INSPECTED BY LIKO'S LOCAL DISTRIBUTOR THREE DAYS LATER. UPON INSPECTION IT WAS OBSERVED THAT THE SLING HANGER BAR'S ADAPTER HAD BEEN REMOVED. THIS UNAPPROVED COMPONENT REMOVAL LED TO UNSAFE SIDE LOAD FORCES UPON THE HANGER BAR'S CENTER BOLT, WHICH BROKE DURING THE LIFT. IT IS THE POSITION OF LIKO INC. THAT IF THE ADAPTER HAD NOT BEEN REMOVED THE EQUIPMENT WOULD NOT HAVE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIKING PATINET LIFT/HOIST FSA LIKE AB VIKING M *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other