BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 17782688 · Received September 20, 2023

    Report

    Report Number
    8030916-2023-00063
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 20, 2023
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIKORALL OVERHEAD LIFT IS A GENERAL-PURPOSE LIKO LIFT WITH THE INTENDED USE AS AN AID IN LIFTING AND TRANSFERRING PATIENT IN: HEALTH CARE, INTENSIVE CARE AND REHABILITATION. THE SLINGBAR COMPOSITE HOOKS HOLD THE ASSOCIATED SLING STRAPS DURING A PATIENT TRANSFER. THE DEVICE IFU INSTRUCTS TO CHECK THE DEVICE FOR DAMAGE AND THE FUNCTION OF THE DEVICE'S LATCHES PRIOR TO USE. IN ADDITION, ¿BEFORE LIFTING ALWAYS MAKE SURE THAT THE SLINGS STRAP LOOPS ARE CORRECTLY CONNECTED TO THE SLING BAR HOOKS, CHECK THAT ALL SUSPENSION LOOPS HAVE THE SAME LENGTH, ARE AT AN EQUAL HEIGHT WHEN THEY ARE STRETCHED PRIOR TO LIFTING THE PATIENT FROM THE UNDERLYING SURFACE.¿ THE CUSTOMER PROVIDED A PICTURE OF THE BROKEN COMPOSITE SLING BAR HOOK. THE PICTURE CONFIRMS A FRACTURE IN THE COMPOSITE HOOK. 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! A BRUISE OR HEMATOMA IS AN INJURY TO TISSUES WITH SKIN DISCOLORATION AND WITHOUT BREAKAGE OF SKIN. BLOOD FROM THE BROKEN VESSELS ACCUMULATES IN SURROUNDING TISSUES, WHICH MAY PRODUCE PAIN, SWELLING, TENDERNESS, AND DISCOLORATION OF THE SKIN. MOST BRUISES/HEMATOMAS HEAL WITHOUT TREATMENT, COLD COMPRESSES MAY REDUCE BLEEDING IF APPLIED IMMEDIATELY AFTER THE INJURY, AND MAY REDUCE SWELLING, DISCOLORATION, AND PAIN IN THIS EVENT THE PATIENT REPORTEDLY SUSTAINED A HEMATOMA, NO MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT SUSTAIN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, WHICH CONCLUDES NO SERIOUS INJURY OCCURRED. ALTHOUGH THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THE REPORTED EVENT, THE REPORT OF THE SLING BAR HOOK BREAKING DURING PATIENT LIFT COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, HILLROM CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE THE OCCUPATIONAL THERAPIST WAS HANDLING THE PATIENT USING THE LIKORALL 200 LIFT, ONE OF THE SLING BAR'S COMPOSITE HOOKS BROKE OFF CAUSING THE PATIENT TO FALL BACK ONTO THE BED. THE PATIENT WAS REPORTED TO HAVE SUSTAINED A HEMATOMA IN AN UNDISCLOSED AREA. MEDICAL INTERVENTION, IF ANY, WAS NOT REPORTED THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77206 UNIVERSAL SLINGB 450 QRH OVERHEAD TRACK PATIENT LIFTING/TRANSFER SYSTEM FSA LIKO AB 3121001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown