BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI MOVE

    MDR report key: 1403253 · Received June 15, 2009

    Report

    Report Number
    9611530-2009-00036
    Event Type
    Death
    Date Received
    June 15, 2009
    Date of Event
    May 28, 2009
    Report Date
    June 15, 2009
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT TWO CAREGIVERS WERE PRESENT AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE FIRST CAREGIVER WAS PREPARING TO MOVE THE RESIDENT FROM HER BED INTO A WHEELCHAIR. SHE PLACED THE SLING UNDER THE RESIDENT AND THEN MOVED THE LIFT INTO POSITION BY THE BED. SHE LOWERED THE HANGER BAR TO HOOK THE SLING CLIPS TO THE HANGER BAR. SHE CONNECTED THE CLIPS TO THE HANGER BAR. SHE THEN LEFT THE ROOM FOR APPROXIMATELY 30 MINUTES. WHEN SHE RETURNED, SHE BROUGHT THE SECOND CAREGIVER WITH HER. THE FIRST CAREGIVER THEN LIFTED THE RESIDENT ABOVE THE BED AND BEGAN TO MOVE THE LIFT BACK AWAY FROM THE BED. THE RESIDENT WAS FACING AWAY FROM THE MAST AND WAS IN A SITTING POSITION IN THE SLING. AT THIS TIME A LOUD CLICKING NOISE WAS HEARD. AT THIS POINT, THE TWO CAREGIVERS PROVIDE DIFFERENT DESCRIPTIONS OF THE EVENT. MFR. REPORT NO. 1345. THE FIRST CAREGIVER STATES THAT AFTER HEARING THE CLICKING SOUND, BOTH CROTCH SLING CLIPS CAME OFF AND THE RESIDENT SLIPPED THROUGH AND HIT HER HEAD ON THE MAST. THE SECOND CAREGIVER STATES THAT AFTER HEARING THE CLICKING SOUND, THE CLIP NEAREST THE RESIDENT'S RIGHT SHOULDER CAME OFF AND THE RESIDENT FELL OFF TO THE RIGHT SIDE, SPUN COUNTER CLOCKWISE TOWARDS THE BASE OF THE LIFT AND STRUCK THE BASE OF THE LIFT WITH HER HEAD. THE RESIDENT WAS TAKEN TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH A SKULL HEMATOMA, A LACERATION OF THE RIGHT EAR LOBE AND A FRACTURED C2. THE RESIDENT EXPIRED IN 2009. THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PATIENT LIFT FNG ARJO HOSPITAL EQUIPMENT AB KMBB4XXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death