BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 18838080 · Received March 5, 2024

    Report

    Report Number
    8030916-2024-00012
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 5, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION, IT WAS CONFIRMED THAT THERE WAS A BREAK IN THE COMPOSITE HOOK PART OF THE SLINGBAR. THE FIELD SERVICE TECHNICIAN REPLACED THE SLINGBAR TO RESOLVE THE ALLEGED ISSUE. THE UNIVERSAL SLINGBAR CAN BE USED IN COMBINATION WITH LIKO SLINGS THAT ATTACHES TO THE SLING BAR USING SLING LOOPS. LIKO´S UNIVERSAL SLING BARS ARE WITH TWO ASSEMBLY OPTIONS, FIXED ASSEMBLY OR WITH QUICK-RELEASE HOOK. HILLROM INVESTIGATION ON PREVIOUS SIMILAR CASES CONCLUDES THAT THE UNIVERSAL SLINGBAR WILL NOT BREAK IF IT IS USED AS INTENDED. THE UNIVERSAL SLINGBAR CAN HOLD THE LOAD IT IS DESIGNED FOR IF THE LOAD IS APPLIED ACCORDING TO INSTRUCTION FOR USE. TESTS DEMONSTRATE THAT THE COMPOSITE HOOKS ON THE UNIVERSAL SLINGBAR CAN WITHSTAND MORE THAN 780 KG LOAD UNTIL BREAKAGE. OUR INVESTIGATION FURTHER SHOWS THAT THE BREAKAGE OF THE COMPOSITE HOOK CAN OCCUR AT LOWER WEIGHT IF THE LOAD IS NOT CENTERED, THE LOAD IS APPLIED IN ONLY ONE HOOK OR THE LOAD IS NOT APPLIED INSIDE THE HOOK AS INTENDED. IN THE INSTRUCTION FOR USE FOR UNIVERSAL SLING BARS (7EN160185 REV 5), THE SAFETY INSTRUCTION SECTION STATES: - BEFORE LIFTING, ALWAYS MAKE SURE THAT THE SLING¿S STRAP LOOPS ARE CORRECTLY FASTENED TO THE SLING BAR HOOKS WHEN THE SLING STRAP IS EXTENDED, BUT BEFORE THE PATIENT IS LIFTED FROM THE UNDERLYING SURFACE. - FOR SAFETY, LOAD MUST BE APPLIED TO ALL SLING BAR HOOKS ON THE SLING BAR DURING THE LIFT! ALTHOUGH THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THE REPORTED EVENT, IF THE SLING BAR HOOK WERE TO BREAK DURING PATIENT LIFT, IT COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THEREFORE, HILLROM CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THE SLINGBAR OF THE LIFT WAS BROKEN. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261662 UNIVERSAL SLINGB 450 QRH LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3156085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown