BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNO 102 ES

    MDR report key: 19739067 · Received July 15, 2024

    Report

    Report Number
    8030916-2024-00033
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 15, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNO 102 MOBILE LIFT HAS ELECTRIC RAISING AND LOWERING OF THE LIFT ARM. UNO MOBILE LIFT IS INTENDED MAINLY FOR USE IN POST ACUTE CARE FACILITIES LIKE NURSING HOMES AND OTHER CARE HOMES IN THE MOST COMMON LIFTING SITUATIONS, FOR INSTANCE, TRANSFERS BETWEEN BED AND WHEELCHAIR, TO AND FROM TOILET AND FOR LIFTING TO AND FROM THE FLOOR. UNO MOBILE LIFT HAS THREE ALTERNATIVE HEIGHT SETTINGS, IN ORDER ALWAYS TO PROVIDE THE OPTIMUM LIFTING HEIGHT. THE DEVICE INSTRUCTION FOR USE STATES: "BEFORE LIFTING, ALWAYS MAKE SURE THAT 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." "CHECK THE SLING BAR LATCHES ARE INTACT. MISSING OR DAMAGED LATCHES MUST ALWAYS BE REPLACED WITH NEW ONES;" AN INSPECTION PERFORMED BY A BAXTER TECHNICIAN NOTED THAT THE DEVICE WAS FUNCTIONING AS DESIGNED, NO MALFUNCTION WAS IDENTIFIED. DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE SLING BAR INVOLVED IN THE REPORTED EVENT WAS A LIKO UNIVERSAL SLINGBAR PN 3156075, AND THE SLING WAS A UNIVERSAL SLING SIZE M PN 35000115. NO FURTHER INFORMATION WAS PROVIDED. THE FUNCTION OF THE LATCHES IN THE HILLROM UNIVERSAL SLINGBAR IS TO PREVENT THE SLING HARNESSES FROM MIGRATING OUT OF THE SLING BAR HOOK WHEN THE HARNESS IS SLACKED, FOR EXAMPLE, WHEN NO PATIENT IS BEING LIFTED IN THE SLING. THESE LATCHES MAKE IT EASIER FOR THE CAREGIVER TO ATTACH THE SLING LOOPS TO THE SLING BAR HOOKS, PREVENTING THE SLING LOOPS FROM MOVING OUT OF THE HOOKS DURING PREPARATION AND BEFORE THE PATIENT IS LIFTED. WHEN USED AS INTENDED, THE LATCHES ARE NOT SUBJECTED TO FORCES AND WILL NOT DISCONNECT FROM THE SLING BAR. WHEN THE SLING LOOP IS NOT PROPERLY RESTING IN THE HOOK, OR IS PARTIALLY ATTACHED AROUND THE LATCH, THE LATCHES FOR THE MAY DETACH EARLY IN THE LIFTING PROCESS WHEN SUBJECTED TO MINIMAL FORCE. THIS DESIGN PREVENTS A PATIENT FROM BEING LIFTED TO A HEIGHT WHICH COULD BE POTENTIALLY HAZARDOUS WHILE THE SLING HARNESS IS IMPROPERLY ATTACHED. IN THIS EVENT, IT WAS REPORTED THAT THE PATIENT FELL DURING A TRANSFER WITH AN UNO 102 LIFT AND REQUIRED IMMOBILIZATION OF THE RIGHT KNEE WITH A SPLINT TO PRECLUDE A PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, WHICH CONCLUDES A SERIOUS INJURY OCCURRED. ADDITIONALLY, THERE WAS NO REPORT OF DEVICE MALFUNCTION, AND NO MALFUNCTION WAS IDENTIFIED UPON INSPECTION. BASED ON THE INFORMATION PROVIDED THAT THE CARE ASSISTANT "DID NOT LOCK THE SLING BAR LATCH", IT IS REASONABLE TO CONCLUDE THAT THE EVENT WAS LIKELY DUE TO A USE ERROR/MISUSE OF THE DEVICE IN THE ATTACHMENT OF THE SLING TO THE LIFT'S SLING BAR. PREVENTION OF THIS TYPE OF EVENTS IS OUTLINED IN THE DEVICE IFU AS MENTIONED ABOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FELL DURING A TRANSFER WITH AN UNO 102 LIFT, AND SUSTAINED A HEMATOMA OF THE LEFT TEMPORAL BONE, REQUIRED IMMOBILIZATION OF THE RIGHT KNEE WITH A SPLINT, AND ANALGESIC MEDICATIONS. NO X-RAYS OR OTHER TESTS WERE PERFORMED, AND NO FURTHER MEDICAL CONSEQUENCES WERE REPORTED. IT WAS REPORTED BY THE CUSTOMER THE CARE ASSISTANT IN CHARGE OF THE TRANSFER THOUGHT THEY HAD NOT LOCKED THE SLING BAR LATCH, THE SLING'S LOOP SLIPPED OUT, RESULTING IN THE PATIENT FALL. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258574 UNO 102 ES LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB P2010005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention