BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL 200

    MDR report key: 17542130 · Received August 14, 2023

    Report

    Report Number
    8030916-2023-00057
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 14, 2023
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION, THE HRC TECHNICIAN DETERMINED THAT THE EMERGENCY FUNCTION WAS INOPERATIVE. THE ELECTRIC CARD AND COVER WERE REPLACED TO RESOLVE THE REPORTED ISSUE. LIKORALL OVERHEAD LIFT IS A STATIONARY LIFT MOUNTED IN A RAIL SYSTEM. THE RAIL SYSTEM CAN BE BUILT STRAIGHT, WITH OR WITHOUT CURVES, AS A TRAVERSE SYSTEM AND ALSO AS A ROOM-TO-ROOM SYSTEM. LIKORALL OVERHEAD LIFT IS INTENDED FOR USE IN LIFTING AND TRANSFERRING PATIENTS, FOR EXAMPLE, FROM BED TO A WHEELCHAIR, TO OR FROM THE FLOOR, FOR VISITS TO THE TOILET, FOR GAIT, STANDING AND BALANCE TRAINING, WHEN WEIGHING THE PATIENT AND WHEN LIFTING THE PATIENT WITH A STRETCHER. ACCORDING TO HILLROM¿S PERIODIC INSPECTION FOR LIKO MOBILE LIFTS (3EN371001 REV. 4), THE EMERGENCY STOP FUNCTION MUST BE CHECKED AT LEAST ONCE EVERY YEAR. IN THE DOCUMENT IT IS STATED UNDER SECTION 10: PRESS THE EMERGENCY STOP BUTTON. WITH THE EMERGENCY STOP PRESSED IN, VERIFY THE LIFT DOES NOT OPERATE WITH THE HAND CONTROL BUTTONS. TURN THE RED EMERGENCY BUTTON IN THE DIRECTION OF THE ARROWS. VERIFY THE BUTTON RELEASES FROM THE LOCKED POSITION INTO THE RAISED, OPEN POSITION. ALTHOUGH THERE WAS NO REPORTED INJURY AS A RESULT OF THE REPORTED EVENT, THE REPORT OF AN EMERGENCY BUTTON NOT FUNCTIONING DURING PATIENT TRANSFER COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, HILLROM CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THE UNIT¿S COVER WAS DAMAGED. DETAILS OF THE CIRCUMSTANCES THAT LEAD TO THE MALFUNCTION WERE NOT PROVIDED. THERE WAS NO PATIENT OR USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55203 LIKORALL 200 OVERHEAD TRACK PATIENT LIFTING/TRANSFER SYSTEM FSA LIKO AB 3121001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown