BEUDAMED
    FDA Adverse Event Summary report: N

    CENTURY SUPINE TUB LIFT

    MDR report key: 95124 · Received August 2, 1994

    Report

    Report Number
    95124
    Date Received
    August 2, 1994
    Date of Event
    June 1, 1994
    Report Date
    July 25, 1994
    Manufacturer
    ARJO-CENTURY INC.
    Product Code
    FSA
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ON 6/1/94, A NURSING ASSISTANT WAS REMOVING A RESIDENT FROM THE SUPINE TUB. WHILE IN THE PROCESS, THE RESIDENT STARTED MOVING AND SLIPPED OFF THE TUBE LIFT. THE NURSING ASSISTANT HAD ONLY ONE SAFETY BELT OUT OF THREE SECURED AROUND THE RESIDENT'S WAIST. THIS ALLOWED FULL MOVEMENT OF CHEST AND LEG AREAS ALLOWING WAIST BELT TO LOOSEN AND RESIDENT TO FALL OFF THE LIFT. RESIDENT WAS SENT TO THE HOSP FOR X-RAYS AND ADMITTED WITH A RIGHT HIP FRACTURE. THE FACILITY DID A VISUAL, MECHANINCAL AND PERFORMANCE EVAL OF EQUIPMENT AND DETERMINED THAT OPERATOR ERROR CAUSED THE ACCIDENT TO OCCUR, AND NOT EQUIPMENT FAILURE. OPERATOR WAS INSERVICED ON PROPER BATHING TECHNIQUE AND SAFE EQUIPMENT OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY SUPINE TUB LIFT * FSA ARJO-CENTURY INC. 58200-77 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *