BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 14828683 · Received June 27, 2022

    Report

    Report Number
    8030916-2022-00033
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    May 31, 2022
    Report Date
    August 11, 2022
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL FOLLOW UP WITH THE CUSTOMER REVEALED THAT THE HOOK OF THE SLINGBAR BROKE DURING A PATIENT TRANSFER. SO FAR, THE CUSTOMER COULD NOT PROVIDE ANY FURTHER DETAILS ABOUT THE CIRCUMSTANCES THAT LEAD TO THIS EVENT. IT WAS CONFIRMED THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    INITIAL FOLLOW UP WITH THE CUSTOMER REVEALED THAT THE THE HOOK OF THE SLINGBAR BROKE DURING A PATIENT TRANSFER. THE CUSTOMER COULD NOT PROVIDE ANY FURTHER DETAILS ABOUT THE CIRCUMSTANCES THAT LEAD TO THIS EVENT. IT WAS CONFIRMED THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. HILLROM HAS REQUESTED THE CUSTOMER TO RETURN THE SLINGABR INVOLVED IN THIS EVENT BUT SO FAR IT HASN'T BEEN RECEIVED YET. THE CUSTOMER PROVIDED PICTURES OF THE BROKEN COMPOSITE SLING BAR HOOK, DISPLAYING A COMPLETE FRACTURE IN THE COMPOSITE HOOK. THE SLINGBAR WAS REPLACED TO RESOLVE THE 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 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 PATIENT 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. CUSTOMER DID NOT RETURN THE SLINGBAR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE OF THE HOOKS OF THE SLINGBAR BROKE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE OF THE HOOKS OF THE SLINGBAR BROKE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071316 UNIVERSAL SLINGB 450 QRH LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3156085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown