BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIRALL 200

    MDR report key: 14632166 · Received June 8, 2022

    Report

    Report Number
    8030916-2022-00031
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 3, 2022
    Report Date
    June 8, 2022
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AFTER TRANSFERRING A PATIENT TO THE BED WITH USE OF A MULTIRALL 200, THE EMPLOYEE REMOVED THE SLING COMPONENT FROM THE PATIENT¿S UNDERCARRIAGE USING THE DEVICES MOTOR TRACTION AND THE LEFT END OF THE SLING BAR BROKE OFF HITTING THE EMPLOYEE¿S FOREHEAD. THE PATIENT WAS UNHARMED, BUT ONE OF THE TWO EMPLOYEES SUFFERED A FRONTAL HEMATOMA WITH A WOUND (BANDAGE TO HEAD) AND SPENT THE NIGHT IN THE HOSPITAL. IT IS ADDITIONALLY NOTED THAT THE EMPLOYEE HAD AN EMERGENCY ROOM VISIT THE FOLLOWING NIGHT FOR LOSS OF CONSCIOUSNESS AND WAS PLACED OUT OF WORK FOR ONE MONTH. THE MULTIRALL 200 OVERHEAD LIFT IS A GENERAL-PURPOSE LIFT WITH THE INTENDED USE IN: HEALTH CARE, INTENSIVE CARE, AND REHABILITATION. MULTIRALL 200 OVERHEAD LIFT IS EASY TO MOVE BETWEEN FACILITIES AND USEFUL FOR ROOM-TO-ROOM TRANSITIONS. INTENDED FOR USE IN ALL COMMON LIFT AND TRANSFER SITUATIONS, FOR EXAMPLE, BETWEEN BED/WHEELCHAIR, TO/FROM FLOOR, TOILET VISITS, GAIT TRAINING, AND FOR HORIZONTAL LIFTS WITH STRETCHERS. LIFT INSTRUCTIONS FOR USE (IFU) STATE USING LIFTING ACCESSORIES OTHER THAN THOSE APPROVED CAN ENTAIL A RISK. BEFORE LIFTING, ALWAYS MAKE SURE THAT: (1) THE LIFT STRAP IS NOT TWISTED OR WORN AND CAN MOVE IN AND OUT OF THE LIFT FREELY. (2) THE LIFTING ACCESSORIES ARE NOT DAMAGED. (3) THE LIFTING ACCESSORY IS CORRECTLY AND SAFELY APPLIED TO THE PATIENT IN ORDER TO PREVENT INJURIES. (4) THE LIFTING ACCESSORIES ARE PROPERLY ATTACHED TO THE LIFT. (5) THE LIFTING ACCESSORIES HANG VERTICALLY AND CAN MOVE FREELY. (6) THE SLING BAR LATCHES ARE INTACT; MISSING OR DAMAGED LATCHES MUST ALWAYS BE REPLACED. (6) THE SLING¿S STRAP LOOPS ARE CORRECTLY CONNECTED TO THE SLING BAR HOOKS WHEN THE SLING STRAPS ARE EXTENDED, BUT BEFORE THE PATIENT IS LIFTED FROM THE UNDERLYING SURFACE. IFU INSPECTION AND MAINTENANCE NOTE FOR TROUBLE-FREE USE, CERTAIN DETAILS SHOULD BE CHECKED EACH DAY THE LIFT IS USED: INSPECT THE LIFT AND CHECK TO MAKE SURE THAT THERE IS NO EXTERNAL DAMAGE, CHECK THE SLING BAR ATTACHMENT, CHECK THE LIFT STRAP FOR WEAR AND TO ENSURE THE STRAP IS NOT TWISTED, CHECK THE FUNCTIONALITY OF THE LATCHES, CHECK THE CONTROL FUNCTION OF THE LIFT MOVEMENT, CHECK TO MAKE SURE THAT THE EMERGENCY LOWERING WORKS, CHARGE THE BATTERIES EACH DAY THE LIFT IS USED AND CHECK TO ENSURE THE CHARGER WORKS. A PERIODIC INSPECTION OF THE LIFT SHOULD BE CARRIED OUT AT LEAST ONCE PER YEAR. INSPECTION OF THE DEVICE BY A HILLROM TECHNICIAN NOTED NO OTHER MALFUNCTION AS THE LIFT WAS FUNCTIONING AS DESIGNED ONCE THE SLINGBAR WAS REPLACED. A HEMATOMA ON THE HEAD IS A HAEMORRHAGE THAT OCCURS AFTER A BLOW OR SUDDEN PRESSURE BY A HARD OBJECT OR SURFACE. WITH THIS TYPE OF INJURY, BLOOD ACCUMULATES IN THE TISSUES. IN SOME CASES, A HEMATOMA WILL NOT REQUIRE TREATMENT AND THE BODY WILL USUALLY REABSORB THE BLOOD OVER TIME. IT MAY HELP TO WRAP OR SPLINT THE AREA AROUND THE HEMATOMA TO KEEP THE BLOOD VESSEL FROM REOPENING AS IT HEALS. DOCTORS MAY RECOMMEND OVER THE COUNTER OR PRESCRIPTION PAIN RELIEVERS IF THE INJURY IS PAINFUL. SOMETIMES, A HEMATOMA MAY REQUIRE SURGICAL DRAINAGE. SURGERY MAY BE MORE LIKELY IF THE BLOOD IS PUTTING PRESSURE ON THE SPINAL CORD, BRAIN, OR OTHER ORGANS. IN OTHER CASES, DOCTORS MAY WANT TO DRAIN A HEMATOMA THAT IS AT RISK OF INFECTION. THE EVENT WAS LIKELY DUE TO USER ERROR (UNSAFE PROCEDURE) AS IT IS NOTED THAT THE EMPLOYEES WERE REMOVING THE SLING FROM UNDER THE PATIENT USING THE LIFT AND NOT DETACHING FROM BOTH SIDES OF THE SLING BAR. PROCEDURES FOR PREVENTION OF THIS TYPE OF EVENT ARE OUTLINED PER THE IFU AS NOTED ABOVE. BASED ON THE INFORMATION PROVIDED THAT OVERNIGHT HOSPITALIZATION WAS REQUIRED, AND THE EMPLOYEE HAD SUBSEQUENT LOSS OF CONSCIOUSNESS WITH ONE MONTH OFF WORK, HILLROM IS REPORTING THIS EVENT DUE TO THE SERIOUS INJURY INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER TRANSFERRING A PATIENT TO THE BED WITH USE OF A MULTIRALL 200, THE EMPLOYEE REMOVED THE SLING COMPONENT FROM THE PATIENT¿S UNDERCARRIAGE USING THE DEVICES MOTOR TRACTION AND THE LEFT END OF THE SLING BAR BROKE OFF HITTING THE EMPLOYEE¿S FOREHEAD. THE PATIENT WAS UNHARMED, BUT ONE OF THE TWO EMPLOYEES SUFFERED A FRONTAL HEMATOMA WITH A WOUND (BANDAGE TO HEAD) AND SPENT THE NIGHT IN THE HOSPITAL. IT IS ADDITIONALLY NOTED THAT THE EMPLOYEE HAD AN EMERGENCY ROOM VISIT THE FOLLOWING NIGHT FOR LOSS OF CONSCIOUSNESS AND WAS PLACED OUT OF WORK FOR ONE MONTH.THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS C-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290118 MULTIRALL 200 LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3130001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization