BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALENTI

    MDR report key: 2110044 · Received May 26, 2011

    Report

    Report Number
    9611530-2011-00044
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    PER THE ARJOHUNTLEIGH (B)(4) EQUIPMENT CONSULTANT: "THE RESIDENT NAMED WAS FINISHING HER BATH, WHEN THE LIFT LOWERED AND BECAME UNBALANCED CAUSING THE LIFT TO TILT. THE STAFF STATED THE RESIDENT WAS NOT ENTIRELY OVER THE TUB, POSSIBLY WITH JUST A CORNER OF THE LIFT CHAIR SEAT BEING OVER THE EDGE OF THE TUB. THE RESIDENT WAS IN THE PROCESS OF GETTING DRIED OFF AND DRESSED. STAFF FEEL SHE MAY HAVE ACCIDENTLY LEANED ON THE HAND CONTROL CAUSING THE LIFT TO LOWER. IN DOING SO CAUGHT THE EDGE OF THE TUB WITH THE LIFT SEAT. THIS CAUSED THE RESIDENT TO TIP OFF THE FRONT SIDE OF THE LIFT. THE LIFT WAS FOUND TURNED COMPLETELY ON ITS SIDE WITH THE RESIDENT SITTING ON THE FLOOR BESIDE THE TUB. PRIOR TO INCIDENT SHE WALKED WITH A WALKER AND NEEDED ASSISTANCE WITH ADL." THE (B)(4) EQUIPMENT CONSULTANT ALSO PREVIOUSLY STATED THAT THE SAFETY BELT WAS NOT USED. THE RESIDENT SUFFERED BRUISING TO THEIR RIGHT SIDE AND TO THEIR LEG; X-RAYS WERE TAKEN BUT THERE WAS NO FRACTURE FOUND.

    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 93 YR Hospitalization| O