BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 2551688 · Received April 23, 2012

    Report

    Report Number
    9611530-2012-00064
    Event Type
    Injury
    Date Received
    April 23, 2012
    Date of Event
    March 31, 2012
    Report Date
    April 2, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. (1419652) ON BEHALF OF THE MFR ARJO (B)(4), 9611530. (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    STATED BY THE CUSTOMER (B)(6) 2012: THE (B)(6) SERVICE TECH'S DESCRIPTION OF EVENT: "AT 11/20 AM 2 AIDS (ONE AT THE DOCKING HANDLES AND ONE AT THE RESIDENT) WERE TRANSFERRING THE RESIDENT FROM THE BED TO THE CHAIR IN THE PTS ROOM. AFTER THE RESIDENT WAS RAISED AND MOVING FROM THE BED, THE HANGER BAR RELEASE FROM THE JIB. THE RESIDENT FELL TO THE FLOOR HER BACK LANDING OF THE LEG OF THE LIFT, HER HEAD HITTING THE FLOOR, AND THE HANGER BAR FELL ON TOP OF HER CHEST AND HITTING THE BRIDGE OF HER NOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFTS FSA ARJO HOSPITAL EQUIPMENT AB KMBBOLU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention