BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL 242 ES, NATURAL

    MDR report key: 5494806 · Received March 11, 2016

    Report

    Report Number
    8030916-2016-00034
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    February 19, 2016
    Report Date
    February 19, 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 LIFT, HE COULD NOT DETECT ANY FAILURE WITH THE PRODUCT. THE BATTERIES NEEDED TO BE REPLACED, BUT WAS NOT RELATED TO THE CAUSE OF THE INCIDENT. ACCORDING TO 7EN120115 REV. 6 "LIKORALL 242/243/250 INSTRUCTION GUIDE," HILL-ROM STATES BEFORE LIFTING TO ALWAYS ENSURE 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. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING WHEN TRANSFERRING A PATIENT, THE LIFT STRAP UNEXPECTEDLY LOWERED 30CM. THE LIFT WAS LOCATED IN A PATIENT ROOM AT THE ACCOUNT AT THE TIME OF THE ALLEGATION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152213 LIKORALL 242 ES, NATURAL NON-AC POWERED PATIENT LIFT FSA LIKO AB 3122005

    Patients

    Seq Age Sex Outcome Treatment
    1