BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 15377517 · Received September 8, 2022

    Report

    Report Number
    8030916-2022-00045
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 3, 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

    HILLROM IS IN THE PROCESS OF CONTACTING THE CUSTOMER FOR ADDITIONAL INFORMATION ON THE CIRCUMSTANCES THAT LEAD TO THE EVENT. 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

    ADDITIONAL INFORMATION FROM THE CUSTOMERS BIOMEDICAL TECHNICIAN INFORMS THAT THERE WERE NO INJURIES, THE PATIENT APPARENTLY FELL A SHORT DISTANCE BACK ON THE BED. THE CUSTOMER PROVIDED A PICTURE OF THE BROKEN COMPOSITE SLING BAR HOOK. THE PICTURE SHOWS A FRACTURE IN THE COMPOSITE HOOK. THE SLINGBAR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE ANALYSIS OF THE FRACTURE CAN CONCLUDE THAT IT IS NOT A FRACTURE THAT WOULD COME FROM A SLINGBAR THAT HAS BEEN LOADED WITH CORRECTLY APPLIED SLING LOOPS. THE FRACTURE STARTS IN THE BOTTOM OF THE HOOK AND CONTINUES OUTWARDS FROM THE CENTER OF THE SLINGBAR. THIS SHOWS THAT THE LOAD HAS BEEN APPLIED FURTHER OUT ON THE HOOK, AS IT WOULD BE IF IT IS LOADED TO ONLY ONE HOOK, OR THE LOAD IS NOT APPLIED INSIDE THE HOOK AS DOCUMENTED IN THE INSTRUCTIONS FOR USE. IF THE LOOP OF THE SLING IS APPLIED CORRECT, INSIDE THE HOOK AS INTENDED, THE LOAD FROM THE LOOP WILL LAY IN THE BOTTOM OF THE HOOK. A HOOK WITH THIS LOAD DISTRIBUTION WILL HAVE A FRACTURE THAT STARTS FROM THE BOTTOM OF THE HOOK AND CONTINUES INWARDS TO THE CENTER OF THE SLINGBAR. 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! IT IS ALSO DOCUMENTED IN THE INSTRUCTION FOR USE, BOTH IN TEXT AND IN PICTORIAL ILLUSTRATIONS, HOW THE LOOPS OF THE SLING SHALL BE APPLIED TO THE SLINGBAR AND HOW THE SLING BAR SHALL BE LEVELED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT FELL WHEN A HOOK ON THE SLINGBAR BROKE. THE PATIENT FELL DOWN IN THE BED. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS C-0001756035.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT FELL WHEN A HOOK ON THE SLINGBAR BROKE. THE PATIENT FELL DOWN IN THE BED. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. 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
    2106668 UNIVERSAL SLINGB 450 QRH LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3156085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown