BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIKORAIL 242 S

    MDR report key: 3982902 · Received July 10, 2014

    Report

    Report Number
    8030916-2014-00049
    Event Type
    Other
    Date Received
    July 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION IS POINTING TO A MISSING COMPONENT IN THE RAIL SYSTEM THAT IS DESIGNED TO STOP THE LIFT MOTOR FROM DETACHING FROM THE RAIL SYSTEM AT THE RAIL END. WHEN HILL-ROM TECHNICIAN INSPECTED THE INSTALLATION THE END STOP WAS PRESENT, BUT HILL-ROM SUSPECTS THIS WAS INSTALLED AFTER THE INCIDENT AND BEFORE OUR INVESTIGATION WAS CONDUCTED. ALTHOUGH WE DO NOT PROMOTE OUR PRODUCT TO BE USED IN COMPETITORS RAIL SYSTEMS OUR INVESTIGATION HAS CONCLUDED THAT IF THE END STOP WAS PRESENT THE LIFT MOTOR NOT HAVE DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT AN OVERHEAD STATIONARY LIFT INSTALLED IN A POOL AREA DETACHED FROM THE OVERHEAD RAIL SYSTEM AND FELL INTO THE POOL. IN THE REPORT IT WAS STATED TO HILL-ROM THAT NON-PROFESSIONALS WERE HORSEPLAYING WITH THE LIFT AT THE TIME OF THE INCIDENT. DURING INVESTIGATION, IT WAS FOUND THAT THE LIFT WAS INSTALLED IN A NON-COMPATIBLE COMPETITORS RAIL SYSTEM. NO INJURY WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405304 LIKORAIL 242 S NON-AC POWERED PATIENT LIFT FSA LIKO AB 3122010

    Patients

    Seq Age Sex Outcome Treatment
    1