BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 8678149 · Received June 7, 2019

    Report

    Report Number
    8030916-2019-00028
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 23, 2019
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST PROBABLE CAUSE FOR THE COMPOSITE HOOK TO BREAK IS THE LOAD BEING APPLIED ASYMMETRICALLY ON ONLY ONE SIDE OF THE SLING BAR. TESTS PERFORMED ON UNIVERSAL SLING BARS HAVE SHOWN THAT WHEN THE LOAD IS APPLIED TO BOTH SLING BAR HOOKS, AS PER THE INTENDED USE, THE COMPOSITE HOOK CAN WITHSTAND > 780 KG BEFORE BREAKAGE. IN THE INSTRUCTION GUIDE FOR UNIVERSAL SLING BARS, 7EN160185 REV. 2, IT IS STATED UNDER SAFETY INSTRUCTIONS: 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! THE ACCOUNT WILL REPLACE THE SLINGBAR TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM ACCOUNT STATING THAT THE SLINGBAR HOOK WAS FOUND TO BE BROKEN AFTER A PATIENT LIFT. THERE WAS NO PATIENT OR USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473202 UNIVERSAL SLINGB 450 QRH NON-AC POWERED PATIENT LIFT FSA LIKO AB 3156085

    Patients

    Seq Age Sex Outcome Treatment
    1