BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIKING

    MDR report key: 3111232 · Received May 8, 2013

    Report

    Report Number
    8030916-2013-00025
    Event Type
    Death
    Date Received
    May 8, 2013
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED A PATIENT FELL WHILE BEING LIFTED IN A HILL-ROM LIKO VIKING XL LIFT WITH A NON-HILL-ROM/LIKO SLING BY A CNA. IT WAS REPORTED THE PATIENT DIED AFTER THE INCIDENT. THE INVESTIGATION CONDUCTED BY OUR DISTRIBUTOR INTO THE ALLEGED ISSUE REVEALED THAT ONE OF THE SLING LOOPS WAS IMPROPERLY APPLIED TO THE SLINGBAR. WHEN ATTACHING THE LOOPS OF THE SLING TO THE SLINGBAR, THE CNA DID NOT FULLY SECURE THE LEFT HEAD SLING STRAP LOOP TO THE SLINGBAR HOOK OF THE LIFT. WHEN SHE BEGAN THE LIFT, THE SLING LOOP STRAP WAS RESTING ON TOP SLING BAR HOOK INSTEAD OF INSIDE THE HOOK ITSELF. THE CNA LIFTED THE PATIENT OFF THE BED AND WHEN SHE PULLED THE LIFT AWAY FROM THE BED, THE RESIDENT MOVED AND THE LIFT STRAP TO SLID OFF THE TOP OF THE SLING BAR HOOK. THIS CAUSED THE RESIDENT TO FALL BACKWARD WHERE HIS HEAD HIT THE FLOOR CAUSING MULTIPLE SKULL FRACTURES. IT WAS REPORTED TO HILL-ROM THAT THE FACILITY HAS A 2 PERSON LIFT POLICY THAT WAS VIOLATED BY THIS CNA. NO MALFUNCTIONS WERE NOTED IN THE INVESTIGATION, BUT THE LIFT WAS MISSING THE SLINGBAR LATCHES. ALTHOUGH THESE LATCHES HELP KEEP THE SLING LOOPS IN THE HOOKS BEFORE A LIFT BEGINS, THEY CANNOT PREVENT A HAZARDOUS SITUATION WHERE THE CAREGIVER HAS APPLIED THE SLING LOOP OVER THE END OF THE HOOK, INSTEAD OF INSIDE THE HOOK AS HAD ALLEGEDLY OCCURRED IN THIS INCIDENT. ADDITIONAL TRAINING INSTRUCTIONS ON USING THE LIFT WAS PROVIDED BY THE DISTRIBUTOR ALONG WITH A RECOMMENDATION TO THE CUSTOMER TO BRING THE PRODUCT BACK TO THE MANUFACTURER'S SPECIFICATIONS BY REPLACING THE SLINGBAR LATCHES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202173 VIKING NON-AC POWERED PATIENT LIFT FSA LIKO AB

    Patients

    Seq Age Sex Outcome Treatment
    1