BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 1070447 · Received July 3, 2008

    Report

    Report Number
    9611530-2008-00044
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE LIFTER WAS BEING USED WITH THE LARGE DPS WITH A PT. IT HAD BEEN IN USE FOR APPROXIMATELY FIVE WEEKS WITHOUT A PROBLEM. THE HOIST IS ONLY USED TO LIFT THE PT OFF THE BED TO CHANGE BEDCLOTHES, ETC. THE HOIST IS NOT MOVED WHILE SHE IS OFF THE BED. THE HOIST WAS IN POSITION AND HER RIGHT LEG HAD BEEN CLIPPED TO THE HANGER BAR. WHILE THE NURSE WAS STARTING ON HER LEFT LEG, THE PT NOTICED THAT THE HANGER BAR DID NOT LOOK RIGHT, BUT BEFORE SHE COULD SAY ANYTHING, THE HANGER BAR DROPPED STRAIGHT DOWN. THE PT WAS LIGHTLY HOLDING THE HANGER BAR BY THE UPRIGHTS. SHE STEADIED IT AND THE TWO NURSES TOOK IT OFF HER. THE HANGER BAR WAS APPROXIMATELY 2 INCHES ABOVE THE PT AT ITS LOWEST POINT. THE PT SUSTAINED BRUISES TO THE RIGHT LEG AND HER KNEE WAS HURTING. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PATIENT LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4XXXXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1