BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARJO LIFT BATH TROLLEY

    MDR report key: 58232 · Received December 16, 1996

    Report

    Report Number
    58232
    Event Type
    Malfunction
    Date Received
    December 16, 1996
    Date of Event
    July 30, 1996
    Report Date
    August 8, 1996
    Manufacturer
    ARJO-CENTURY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS IN A SITTING POSITION ON THE CENTER OF THE LIFT WITH LEGS DANGLING TO THE FRONT OFF OF THE LIFT. THE CUSHION THAT THE RESIDENT WAS SITTING ON SLID FORWARD WITH THE RESIDENT, CAUSING THE RESIDENT TO FALL TO THE FLOOR. THE FIRST AND THIRD CUSHIONS WERE DEFINITELY SECURED BUT THERE IS A QUESTION OF WHETHER THE SECOND CUSHION STRAP WAS SECURED. FACILITY HAS SINCE ACQUIRED AN ADD'L SAFETY STRAP. THE STRAPS MUST BE RELEASED FOR CLEANING AND THEN REATTACHED. USER QUESTIONS THE POTENTIAL FOR AN ERROR TO OCCUR WHEN THIS IS A STEP THAT MUST BE DONE PRIOR TO EACH USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO LIFT BATH TROLLEY BATH TROLLEY FSA ARJO-CENTURY, INC. 219100-04 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other