BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SLINGB 450 QRH

    MDR report key: 19748992 · Received July 16, 2024

    Report

    Report Number
    8030916-2024-00035
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 16, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION, THE TECHNICIAN FOUND THE SLINGBAR BOLT WAS BROKEN. THE FIELD SERVICE TECHNICIAN REPLACED THE SLINGBAR TO RESOLVE THE ALLEGED ISSUE. THE UNIVERSAL SLING BAR 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. AS STATED IN THE UNIVERSAL SLING BAR 450 QRH INSTRUCTION FOR USE (7EN160185 REV. 5), CARE AND MAINTENANCE SECTION: A PERIODIC INSPECTION OF UNIVERSAL SLING BARS SHOULD BE CARRIED OUT AT LEAST ONCE A YEAR. WHEN PERFORMING PERIODIC INSPECTION THIS COMPONENT SHALL BE TESTED BY ROTATING THE SLING BAR. IF ANY ABNORMAL MOVEMENT IS DETECTED, THE LIFT WILL NOT PASS THE PERIODIC INSPECTION. PERIODIC INSPECTION, REPAIR AND MAINTENANCE MAY BE PERFORMED ONLY IN ACCORDANCE WITH THE LIKO SERVICE MANUAL BY PERSONNEL AUTHORIZED BY HILL-ROM AND USING ORIGINAL LIKO SPARE PARTS. THE PERIODIC INSPECTION FOR LIKO MOBILE LIFTS (3EN371001 REV 5), SECTION 6 STATES THE FOLLOWING: SLINGBAR. ¿ CHECK THAT THE UNIT ROTATES FREELY ON ITS BEARINGS. MAKE SURE THE SLING BAR DOESN¿T ROTATE UNEVENLY, WOBBLE OR THE SPINNING STOPS DUE TO HIGH FRICTION. ¿ MAKE SURE THAT BOTH LATCHES ARE MOUNTED AND FALL BACK AGAINST THE BODY OF THE SLING BAR. ¿ CHECK THAT THE SLING BAR IS CORRECTLY FASTENED. ¿ MAKE SURE THERE ARE NO DEFORMITIES IN THE ATTACHMENT POINTS. IN THIS EVENT THERE WAS NO REPORT OF PATIENT OR CAREGIVER INJURY. BASED ON PREVIOUS INVESTIGATIONS ON SIMILAR EVENTS, THE REPORTED MALFUNCTION WAS LIKELY DUE TO A FREQUENT AND UNEVEN LOADING OF THE SLING BAR BY THE END USER. IF A SIMILAR MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THE CENTRE PIN THAT HOLDS THE HARNESS ATTACHMENT ARM HAD BROKE. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518053 UNIVERSAL SLINGB 450 QRH LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3156085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown