BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXI 500

    MDR report key: 2824541 · Received October 18, 2012

    Report

    Report Number
    9681684-2012-00080
    Event Type
    Other
    Date Received
    October 18, 2012
    Date of Event
    September 22, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FNG
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR¿S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD¿L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR¿S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED WITH A FLOOR LIFT FROM BED TO CHAIR BY TWO STAFFS. DURING THE TRANSFER, THE RESIDENT BECAME AGITATED AND TRIED TO STRIKE OUT AT THE STAFF. WHEN HE SWUNG HIS ARM AT THE STAFF, THE LIFT TIPPED OVER, STAFF CANNOT CONFIRM IF THE BASE OF THE LIFT WAS OPEN OR CLOSED BUT THE BRAKES WERE NOT ON. RESIDENT HAD LACERATIONS TO THE HEAD AND LEFT ARM, WAS SENT TO EMERGENCY ROOM FOR OBSERVATION AND TREATMENT, BUT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI 500 MANUFACTURED FLOOR PASSIVE LIFT FNG ARJOHUNTLEIGH MAGOG INC. KM560001

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR