BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 8420244 · Received March 14, 2019

    Report

    Report Number
    8030916-2019-00016
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 15, 2019
    Report Date
    February 15, 2019
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT PROVIDED A PICTURE OF THE BROKEN COMPOSITE SLING BAR HOOK. 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. 4), 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! A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS DEVICE. THE FACILITY HAD A THIRD PARTY COMPANY PERFORM PREVENTATIVE MAINTENANCE ON THIS DEVICE. THE ACCOUNT WAS SENT A NEW SLING BAR 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 THE ACCOUNT STATING UNIVERSAL SLINGBAR 450 BROKE. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THE PATIENT FELL BACK ONTO BED. THERE WAS NO ALLEGATION OF PATIENT OR USER INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216375 UNIVERSAL SLINGB 450 QRH NON-AC POWERED PATIENT LIFT FSA LIKO AB 3156085

    Patients

    Seq Age Sex Outcome Treatment
    1