BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 1001834 · Received February 25, 2008

    Report

    Report Number
    9611530-2008-00004
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    October 20, 2007
    Report Date
    February 25, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR EXAMINED THE DEVICE AND FOUND IT IN GOOD CONDITION. THE SEAT BELT HAD BEEN CORRECTLY APPLIED BY THE STAFF, AND THE LIFT WAS AT A LOW POSITION (ABOUT 18-24 INCHES FROM THE FLOOR) AT THE TIME OF THE EVENT. THE FACILITY ADMINISTRATOR FEELS THE STAFF USED TOO MUCH SHAMPOO AND, WHEN FLUSHING THE TUB OUT, THE BUBBLES COME OUT OF THE FLOOR DRAIN. THIS COULD HAVE CONTRIBUTED TO THE SLIPPERY FLOOR. THE MANUFACTURER CONCLUDES THAT MOST LIKELY CAUSE OF THE EVENT IS THE FLOOR BECOMING SLIPPERY DUE TO THE BUBBLES COMING OUT OF THE FLOOR DRAIN. THE MANUFACTURER RECOMMENDS ADDITIONAL TRAINING FOR THE STAFF ON THE USE OF THE CHAIR AND BATHING SYSTEM. THE STAFF IS TO BE NOTIFIED TO USE LESS BODY WASH TO CUT DOWN ON THE BUBBLES. IT HAS ALSO BEEN RECOMMENDED TO ESTABLISH A TRANSFER AREA, AWAY FROM THE FLOOR DRAIN (ARJO WILL ASSIST IN THIS PROCESS). THE FACILITY NOTED THEY DID NOT BELIEVE THE EVENT WAS A RESULT OF THE LIFT FAILURE, BUT RATHER A COMBINATION OF SEVERAL THINGS.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE STAFF MEMBER HAD COMPLETED THE BATH AND WAS REACHING FOR ANOTHER TOWEL TO THE RIGHT OF THE RESIDENT. THE RESIDENT WAS POSITIONED AT THE END OF THE TUB AND THE CHAIR; THE TOWELS WERE TO THE RIGHT OF THE RESIDENT. AS THE STAFF MEMBER REACHED FOR A TOWEL, HER FOOT SLIPPED ON THE FLOOR DRAIN, WHICH WAS IN FRONT OF THE LIFT. THE FLOOR DRAIN IS LARGE (APPROXIMATELY 12 INCHES ACROSS) AND WAS WET WITH BUBBLES COMING OUT OF IT. HER LEFT FOOT WENT UNDER THE LEG OF THE CHAIR AND WAS STARTED TO FALL BACK. SHE GRABBED THE GREY ARM OF THE LIFT TO STOP HERSELF FROM FALLING; THE RESIDENT STARTED TO REACH OUT TO HELP THE STAFF MEMBER. AS THE RESIDENT REACHED OUT, THE LIFT STARTED TO TIP MORE UNTIL FINALLY IT FELL COMPLETELY OVER. THE RESIDENT AND THE LIFT LANDED ON TOP OF THE STAFF MEMBER. THE STAFF MEMBER WAS ABLE TO GET OUT FROM UNDER THE RESIDENT AND CALL FOR HELP. THE RESIDENT WAS ASSESSED AND ALL WAS FINE. ONCE THEY LIFTED THE RESIDENT OFF THE FLOOR AND ONTO THE CHAIR, THEY NOTICED HER LEFT LEG TURNING OUTWARD, WHICH INDICATED A FRACTURE. THE RESIDENT WAS SENT TO THE HOSPITAL. THE RESIDENT SUSTAINED A FRACTURE TO THE LEFT HIP, PAIN IN HER LEFT ARM, AND A BRUISE TO THE LEFT FOREHEAD. THE STAFF MEMBER SUSTAINED BRUISING TO THE LEFT TEMPLE AND WAS STIFF AND SORE IN HER ARMS AND LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI LIFT HYGEINE CHAIR FSA ARJO HOSPITAL EQUIPMENT AB CDBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention