BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALENTI

    MDR report key: 865523 · Received June 17, 2007

    Report

    Report Number
    9611530-2007-00024
    Event Type
    Death
    Date Received
    June 17, 2007
    Date of Event
    April 28, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT, TUB, AND STAFF MEMBERS WERE NOT MADE AVAILABLE TO ARJO FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THAT AT APPROXIMATELY 7:10AM, THE STAFF HAD POSITIONED THE RESIDENT AT THE END OF THE TUB WITH THE RESIDENT FACING AWAY FROM THE END OF THE TUB AND WITH THE PILLAR CONTROLS OF THE LIFT ON THE RIGHT SIDE OF THE RESIDENT. THE DON BELIEVES THE TUB WAS IN A LOW POSITION - BECAUSE THE LIFT WOULD HAVE BEEN RAISED - AND THE TUB LOWERED IN ORDER TO REMOVE THE RESIDENT ON THE LIFT FROM THE TUB. THE SEAT BELT WAS APPLIED. THE DON ESTIMATES THAT THE CHAIR OF THE LIFT MAY HAVE BEEN APPROXIMATELY "WAIST-HEIGHT" TO THE CAREGIVER TO DRY THE RESIDENT. THE STAFF LEFT THE RESIDENT TO MOVE TO THE LEFT SIDE OF THE TUB, REACH OVER THE TUB, RETRIEVE THE SHOWER HANDLE ON THE RIGHT SIDE OF THE TUB AND BEGIN SPRAYING SOIL OUT OF THE TUB SHELL AND DOWN THE DRAIN OF THE TUB. AS THE STAFF MEMBER BEGAN TO SPRAY THE TUB, SHE HEARD A "BANG" AND UPON TURNING TO LOOK, FOUND THE RESIDENT AND BATH CHAIR FALLEN TO THE FLOOR. RESIDENT WAS STILL BUCKLED INTO THE SAFETY BELT ON THE LIFT. A SECOND RESPONDER ARRIVED, RELEASED THE BELT AND REMOVED THE LIFT FROM THE TOP OF THE RESIDENT. IMMEDIATE FIRST AID WAS TO APPLY COMPRESSION TO THE BLEEDING FROM A LACERATION TO THE RIGHT EYEBROW AND LEFT EAR AND A FRACTURE OF THE RIGHT WRIST. RESIDENT PASSED AWAY SOME TIME BEFORE 7AM THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI PATIENT LIFTER FSA ARJO HOSPITAL EQUIPMENT AB CDBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention