BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSALSLING,M

    MDR report key: 10022005 · Received May 4, 2020

    Report

    Report Number
    8030916-2020-00020
    Event Type
    Death
    Date Received
    May 4, 2020
    Date of Event
    April 12, 2020
    Report Date
    May 4, 2020
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIKO UNIVERSAL SLING WAS INSPECTED BY THE CUSTOMER AND NO DEFECTS WERE IDENTIFIED. THE SLING FUNCTIONED AS DESIGNED. THE ACCOUNT COMBINED THE LIKO UNIVERSAL SLING WITH A NON-LIKO PATIENT LIFT. THIS COMBINATION IS NOT RECOMMENDED ACCORDING TO THE LIKO UNIVERSAL SLING INSTRUCTION GUIDE (7EN161110 REV 8). LIKO UNIVERSAL SLING INSTRUCTIONS FOR USE (IFU) INCLUDES A CHART OF LIKO RECOMMENDED COMBINATIONS OF THE LIKO UNIVERSAL SLING AND LIKO'S SLING BARS. ADDITIONALLY, THE IFU INCLUDES THE FOLLOWING STATEMENT: COMBINATIONS OF ACCESSORIES/PRODUCTS OTHER THAN THOSE RECOMMENDED BY LIKO CAN RESULT IN RISKS FOR THE SAFETY OF THE PATIENT. AS NO SERIAL NUMBER WAS PROVIDED FOR THIS LIFT, A SEARCH OF THE HILLROM MAINTENANCE RECORDS FOR ANY HILLROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS LIFT WAS UNABLE TO BE COMPLETED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR LIFT. THE PATIENT'S FALL AND SUBSEQUENT DEATH IS LIKELY DUE TO THE UTILIZATION OF A LIKO UNIVERSAL SLING AND A NON LIKO SLING BAR AND LIFT. THEREFORE, THIS EVENT WILL BE REPORTED AS USE ERROR. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT A LIKO UNIVERSAL SLING HAS BEEN USED WITH GULDMANN GH3 200 LIFT AND SLINGBAR. DURING THE LIFT THE PATIENT FELL OUT OF THE SLING, HIT HER HIP AND HEAD ON THE FLOOR, AND SUBSEQUENTLY EXPIRED AFTER THE FALL. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS MEDICAL COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485369 UNIVERSALSLING,M NON-AC POWERED PATIENT LIFT FSA LIKO AB 35000315

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death