BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALENTI

    MDR report key: 2111025 · Received May 10, 2011

    Report

    Report Number
    9611530-2011-00039
    Event Type
    Other
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESIDENT WAS NOT SITTING THE CORRECT WAY, AS HE WAS FACING THE FRONT OF THE HOIST WITH HIS BACK TO THE PUSH HANDLES. THE USERS STATED THAT THEY HAD ALWAYS BEEN TAUGHT TO PUT THE RESIDENT IN THE HOIST WITH THEIR BACK TO THE PUSH HANDLES; A BACK REST WAS NOT LOCATED ON THE HOIST AND THE USERS DO NOT REMEMBER EVER HAVING ONE. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE ARJOHUNTLEIGH INVESTIGATOR FOUND THAT THE RESIDENT WAS A TALLER GENTLEMAN SITTING IN THE CHAIR WHILE ATTACHED TO THE ALENTI HOIST IN THE SHOWER CUBICLE. THE HOIST WAS RAISED APPROX HALF WAY AS THE USER WAS SO TALL; THIS WAS SO HIS FEET WERE JUST HIGH ENOUGH TO CLEAR THE FLOOR. THEY WERE MANEUVERING THE HOIST SIDEWAYS AS THERE IS NOT MUCH CLEARANCE IN THE SHOWER CUBICLE TO TURN THE HOIST, WHEN THE CASTORS HIT THE GUTTERING OUTSIDE THE CUBICLE. IT STOPPED ABRUPTLY AND THE MOMENTUM TIPPED THE HOIST OVER. THE CAREGIVER WAS TRAPPED UNDER THE HOIST AS SHE WAS STANDING ON THAT SIDE. THE CAREGIVER WHO WAS PUSHING THE HOIST RECEIVED NO INJURIES. THE CAREGIVER WHO WAS TRAPPED AND THE RESIDENT SUFFERED SOME BRUISING, BUT THAT WAS THE EXTENT OF THE REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI HYGIENE AND POOL LIFTER FSA ARJO HOSPITAL EQUIPMENT AB CDB8000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other