BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 2163449 · Received July 4, 2011

    Report

    Report Number
    9611530-2011-00051
    Event Type
    Injury
    Date Received
    July 4, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJO HOSPITAL EQUIPMENT AB (REGISTRATION (B)(4)). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS IN BED, AND THE TWO NURSING STAFF MEMBERS FIRST ATTACHED THE LEG CLIPS OF THE SLING AND THEN THE SHOULDER CLIPS. THEY LIFTED THE RESIDENT FROM THE BED AND THEN POSITIONED HER IN THE SITTING POSITION AND MOVED HER AWAY FROM THE BED. AT THIS TIME, THE RIGHT SHOULDER CLIP CAME UNDONE AND THE RESIDENT FELL OUT OF THE SLING, HITTING HER HEAD AGAINST THE LEG OF THE LIFTER. THE RESIDENT SUFFERED A CUT ON HER HEAD, SKIN TEARS ON HER LEGS, AND SOME BRUISING ON HER LEGS AND HIP. THE CUT WAS GLUED AND X-RAYS WERE TAKEN, BUT NO OTHER RESULTS WERE GIVEN BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4OSU2FAU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R