BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMOVE LIFT

    MDR report key: 559246 · Received February 10, 2004

    Report

    Report Number
    559246
    Event Type
    Malfunction
    Date Received
    February 10, 2004
    Date of Event
    January 26, 2004
    Report Date
    February 5, 2004
    Manufacturer
    ARJO MANUFACTURING COMPANY
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    IN 04 AT 11:30 A.M., THE CERTIFIED NURSING ASSISTANT POSITIONED THE ARJO LIFT OVER THE RESIDENT'S BED (RESIDENT WAS LYING IN BED WITH THE CANVAS ALREADY IN PLACE UNDERNEATH RESIDENT) TURNED THE "SPREADER BAR" AROUND, AND PREPARED TO ATTACH THE CANVAS. THE HANDLE WAS PUSHED AND THE "SPREADER BAR" CAME OFF THE "JIB" AND STRUCK THE RESIDENT ON THEIR MOUTH CAUSING ONE UPPER TOOTH TO BE KNOCKED OUT AND A SMALL CUT TO ANTERIOR LOWER LIP. THE RESIDENT IS DEPENDENT ON THE STAFF FOR TRANSFER IN AND OOB OUT OF THE BED VIA THE USE OF THE ARJO LIFT. THE RESIDENT IS UNABLE TO ASSIST WITH THE TRANSFER IN OR OOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE LIFT LIFT, PATIENT, NON-AC-POWERED FSA ARJO MANUFACTURING COMPANY KRX21171.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR