BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI TWIN

    MDR report key: 18921469 · Received March 18, 2024

    Report

    Report Number
    3007420694-2024-00077
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 22, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT WAS TRANSFERRED FROM A BED TO A SHOWER BY USING A MAXI TWIN PASSIVE FLOOR LIFT AND BATH SLING WITH SERIAL NUMBER (B)(6). THE CAREGIVERS REPORTED THAT IN THE MIDDLE OF A TRANSFER THE LIFT STARTED TO ¿SHAKE¿ AND THE PATIENT FELL OUT FROM THE DEVICE THROUGH THE MIDDLE SECTION OF THE SLING. AS A CONSEQUENCE OF THE EVENT, THE PATIENT SUSTAINED FRACTURE OF THE COLLARBONE AND HUMERUS BONE. DURING THE DEVICE INSPECTION, THERE WAS NO DEVICE MALFUNCTION WHICH MIGHT LEAD TO THE REPORTED DEVICE "SHAKING". THEREFORE, THE CUSTOMER ALLEGATION WAS NOT CONFIRMED. BASED ON INFORMATION PROVIDED DESPITE THE RECOMMENDATION FOR THE PATIENT TO USE A SIZE L SLING, THE CAREGIVERS CHOSE A SIZE XL DURING THE EVENT. MOREOVER, DURING THE INTERVIEW AT THE FACILITY, THE CLINICAL NURSE STATED THAT THE PATIENT WAS PRONE TO MOVEMENT DURING THE TRANSFER DUE TO HER COGNITIVE STATE. THE DESCRIBED SITUATION MIGHT BE A FACTOR OF THE DEVICE SHAKING THAT WAS NOTICED. ACCORDING TO THE PROCEDURES PROVIDED IN THE INSTRUCTIONS FOR THE USE OF THE MAXI TWIN: ¿CROSSED LEG ATTACHMENT - IF THE RESIDENT IS PRONE TO KICKING, THE CROSSED LEG ATTACHMENT THE CLIPS/LOOPS MUST BE APPLIED. THIS PROHIBITS THE LEG CLIPS/LOOPS FROM DETACHMENT DUE TO KICKING AND PREVENTS THE RESIDENT FROM POSSIBLE INJURY." DURING THE INTERVIEW WITH THE CUSTOMER, IT WAS CONFIRMED HOW THE SLING WAS APPLIED DURING THE TRANSFER. THE CUSTOMER STATED THAT THE SLING LEG CLIPS WERE NOT CROSSED. TO SUM UP, THE PATIENT'S SUDDEN MOVEMENT MIGHT LEAD TO DEVICE MOVEMENT AND AS A CONSEQUENCE PATIENT FALL. TO SUM UP, THE ARJO LIFT AND ARJO PASSIVE SLING WERE USED AS A SYSTEM FOR A PATIENT TRANSFER WHEN THE PATIENT FELL OUT OF THE DEVICE AND SUSTAINED A SERIOUS INJURY, AND FROM THAT PERSPECTIVE, THE SYSTEM FAILED. THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO ALLEGATION THAT THE SLING CLIP DETACHED DURING TRANSFER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS TRANSFER FROM A BED TO A SHOWER COMMODE BY ASSISTANCE OF TWO CAREGIVERS. THE CARERS BEGAN MOVING TOWARDS THE CHAIR TO THE RIGHT OF THE BED. DURING THE TRANSFER THE HOIST BEGAN TO ¿SHAKE¿ AND THE PATIENT FELL THROUGH THE MIDDLE SECTION OF THE SLING. AS A CONSEQUENCE OF THE EVENT THE PATIENT SUSTAINED A FRACTURED CLAVICLE AND HUMERUS, THE DEVICE EVLAUATION DID NOT REVEALED ANY DEVICE OR SLING MALFUNCTION. NO SIGNS OF PROBLEM WAS FOUND ON THE HOIST THAT MIGHT CONTRIBUTE TO DEVICE SHAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018954 MAXI TWIN LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH POLSKA SP. Z O.O. KTBB4BSX2AU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Hospitalization