BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL 242 S, NATURAL

    MDR report key: 5890375 · Received August 19, 2016

    Report

    Report Number
    8030916-2016-00104
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 25, 2016
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE TECHNICIAN INVESTIGATED THE LIKORALL 242 S, HE WAS NOT ABLE TO RECREATE THE FAILURE. THE MOST LIKELY ROOT CAUSE IS THAT THE LIFT STRAP WAS FOLDED CAUSING IT TO NOT WIND UP CORRECTLY ON THE DRUM. WHEN A LOAD IS THEN APPLIED, THE LIFT STRAP WILL SLIDE OUT UNTIL IT REACHES ITS UNFOLDED POSITION. ACCORDING TO 7EN120115 REV. 7 "INSTRUCTION GUIDE LIKORALL 242/243/250", HILL-ROM STATES THAT THE USER SHALL MAKE SURE THAT THE LIFT STRAP IS NOT TWISTED OR WORN AND CAN MOVE IN AND OUT OF THE LIFT FREELY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS LIFT. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR LIFTS. THE TECHNICIAN DID NOT REPLACE ANYTHING AND REVIEWED HIS FINDINGS WITH THE ACCOUNT TO RESOLVE THE ISSUE. BASED ON THIS, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING DURING A PATIENT TRANSFER FROM HER BED TO THE ARMCHAIR, THE LIFT STRAP LOWERED A DISTANCE CAUSING THE PATIENT TO DROP. THERE WAS NO PATIENT/USER INJURY REPORTED. THE LIFT WAS LOCATED AT (B)(6) AT THE TIME OF THE INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542925 LIKORALL 242 S, NATURAL NON-AC POWERED PATIENT LIFT FSA LIKO AB 3122009

    Patients

    Seq Age Sex Outcome Treatment
    1