BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL 200

    MDR report key: 23207554 · Received October 3, 2025

    Report

    Report Number
    8030916-2025-00122
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    July 20, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED TO LULEA SITE FOR INVESTIGATION. THE UNIT WAS DISASSEMBLED AND IT WAS CONFIRMED THAT THE MOTOR SHAFT WAS BROKEN. A FUNCTIONAL TEST OF THE SINGLE FAULT SAFETY (SFS) SAFETY DRUM WAS PERFORMED. THE RESULT FROM THE TEST WAS THAT THE SFS SAFETY DRUM WAS FUNCTIONING AS DESIGNED. THIS ISSUE IS DETERMINED TO BE CAUSED BY A MECHANICAL MALFUNCTION (MOTOR SHAFT BREAKAGE). 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. A REPORT OF A DROP WOULD BE UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR AS THE DEVICE HAS A SECONDARY SYSTEM THAT BECOMES ACTIVATED AND PREVENTS THE PATIENT FROM FALLING IN CASE THE PRIMARY SYSTEM FAILS. THE DEVICE MEETS THE REQUIREMENT FOR A SECONDARY SYSTEM WITH A SAFETY FUNCTION THAT STOPS THE PATIENT¿S MOVEMENT DOWNWARDS, IN THE EVENT OF A MOTOR OR TRANSMISSION FAILURE. THIS SAFETY DESIGN PROVIDES PROTECTION AGAINST UNCONTROLLED LOWERING. THERE ARE NO RISKS IDENTIFIED FOR THIS FAILURE DUE TO THE SINGLE FAULT SYSTEM (SFS). AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, NO SERIOUS ADVERSE HEALTH CONSEQUENCE WOULD OCCUR FROM THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR INSPECTION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT THE LIKORALL 200 HAD AN ISSUE, WHILE IN THE PROCESS OF LIFTING UP CITIZEN FROM THE WHEELCHAIR, THE PATIENT WASN'T VERY FAR UP, THEN THE HOIST FELL DOWN AND THE PATIENT LANDED IN THE WHEELCHAIR VERY QUICKLY. NO HARM WAS DONE AS CITIZEN WAS LIFTED A MAXIMUM OF 20-30 CM ABOVE THE WHEELCHAIR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292565 LIKORALL 200 LIFT PATIENT NON AC POWERED FSA BAXTER HEALTHCARE CORPORATION 3121001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown