BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 2110992 · Received April 29, 2011

    Report

    Report Number
    9611530-2011-00033
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE RESIDENT (RES) WAS BEING TRANSFERRED (WITH THE ASSISTANCE OF 2 TRAINED STAFF) FROM BED TO WHEEL CHAIR. THE RES WAS LYING ON HER BED AND PLACED IN A SMALL MESH AH SLING, AND THE MAXI MOVE WAS BROUGHT IN TO COMPLETE THE TRANSFER (WITH ONE MEMBER AT THE REMOTE CONTROLS AND THE OTHER TENDING TO THE RES). THE RES WAS ATTACHED TO THE MAXI MOVE VIA THE CLIP OF THE SLING. THE RES WAS RAISED (A FEW INCHES) AND STOPPED THEN LOWERED DUE TO ONE OF THE LEG AREA SLING CLIPS DETACHING FROM THE SPREADER BAR. THE RES AND SLING WERE REATTACHED (AND INSPECTED TO INSURE PROPER CONNECTIONS OF THE SLING TO THE SPREADER BAR). THE RESIDENT WAS AGAIN RAISED UP USING THE MAXI MOVE, AND WAS TURNED AWAY FROM THE BED AREA LINING UP TO THE WHEEL CHAIR WHEN ONE OF THE LEG CLIPS OF THIS SLING BECAME DETACHED. THE RES WAS SLIPPING OUT OF THE SLING AND WITH THE ASSISTANCE OF THE STAFF MEMBER, THE RES WAS LOWERED TO THE FLOOR, AT WHICH TIME THE RES BUMPED THE BACK OF HER HEAD. THE RES SUFFERED A BUMP TO THE AREA AND WAS TREATED WITH ICE AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFTS FSA ARJO HOSPITAL EQUIPMENT AB KMBB4NSX2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other