BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 3952391 · Received July 2, 2014

    Report

    Report Number
    1419652-2014-00172
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE RESIDENT'S TRANSFER IN THE SLING FROM THE BED TO THE WHEELCHAIR USING THE MAXI MOVE LIFT DEVICE THE RIGHT LEG CLIP DETACHED DUE TO A SUDDEN MOVEMENT OF THE PATIENT. IT WAS INDICATED THAT THE PATIENT WAS LIFTED IN HORIZONTAL POSITION AND BEFORE SHE WAS PUT INTO THE WHEELCHAIR THE PATIENT'S FOOT WAS MANIPULATED TO TURN INTO THE RIGHT POSITION. "THIS LEAD TO A PAINFUL STIMULUS (JACTATION, MYOCLONUS)." THE PATIENT'S RIGHT LEG FELL DOWN. THE RIGHT LEG CLIP OF THE SLING DETACHED AND THIS CAUSED A SUDDEN MOVEMENT BY THE PATIENT (SHE WENT FORWARD) AND THE RIGHT SHOULDER CLIP APPEARED TO BE LOOSE. THE PATIENT STAYED HANGING (HALF) IN THE SLING BUT ALSO HALF TURNED (ANGLED) TO THE WHEELCHAIR. AS A CONSEQUENCE OF THE EVENT THE PATIENT HIT HER FOREHEAD (RIGHT SIDE) ONTO THE JIB WHICH CAUSED A SMALL LACERATION ABOVE THE EYEBROW. NO MEDICAL INTERVENTION WAS NEEDED. REFERENCE MFR # 9611530-2014-00044.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385548 MAXI MOVE FSA ARJO MED AB LTD. KMBO4GSA1F-NL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other