BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALENTI

    MDR report key: 2110900 · Received May 24, 2011

    Report

    Report Number
    9611530-2011-00042
    Event Type
    Other
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY INFORMED THE ARJOHUNTLEIGH REP THAT THE STAFF MEMBER WAS PUSHING THE LIFT FROM THE RED HANDLES AND SHE WAS RAISING THE LIFT AT THE SAME TIME SHE WAS PUSHING THE LIFT TOWARDS THE TUB. THERE IS A DRAIN IN THE MIDDLE OF THE FLOOR THAT COULD HAVE REQUIRED SOME EXTRA EFFORT IN PUSHING THE LIFT TOWARDS THE BATH. THE FLOOR IS ALSO SLOPED WHICH CAUSED THE STAFF TO EXERT MORE EFFORT TO PUSH THE RESIDENT TOWARDS THE TUB. THE CHAIR WAS ABOUT 36 INCHES HIGH WHEN IT TIPPED. A DIFFERENT STAFF MEMBER WHO WAS INVOLVED IN THE INCIDENT SAID THAT SHE DID NOT APPLY THE SEAT BELT TO THIS RESIDENT. THEY ALSO SAID THE RESIDENT LEANS FORWARD ON A REGULAR BASIS AND HAS A LARGE ABDOMINAL APRON. THE FACILITY'S CLINICAL MANAGER HAS MADE CHANGES TO THEIR LIFTING PROCEDURES DUE TO THIS INCIDENT, WHICH WILL BE IMPLEMENTED BY THE FACILITY EDUCATOR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    A SINGLE STAFF MEMBER WAS USING THE ALENTI TO TOILET THE RESIDENT BEFORE PLACING HER IN THE BATH. THE STAFF MEMBER WAS IN THE PROCESS OF MOVING THE RESIDENT FROM THE TOILET AREA TO THE BATH WHEN THE LIFT TIPPED OVER. THE RESIDENT SUFFERED A LARGE BUMP ON THE RIGHT SIDE OF THEIR FOREHEAD, WHICH WAS TREATED WITH ICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI HYGIENE AND POOL LIFTER FSA ARJO HOSPITAL EQUIPMENT AB CDB8053-01

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other