BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTURY TUB

    MDR report key: 624045 · Received August 3, 2005

    Report

    Report Number
    9611530-2005-00010
    Event Type
    Death
    Date Received
    August 3, 2005
    Date of Event
    May 22, 2004
    Report Date
    July 29, 2005
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT WAS ON THE SAF-LIFT WITH THE HIGH-BACK CHAIR AND PUT INTO THE TUB. THE WHIRLPOOL WAS TURNED ON AND THE CAREGIVER LEFT THE ROOM TO GIVE THE CLIENT SOME PRIVACY. AT SOME POINT, THE CAREGIVER CHECKED ON THE CLIENT WHILE THE WHIRLPOOL WAS RUNNING AND THEN LEFT THE ROOM AGAIN. WHEN THE WHIRLPOOL STOPPED (TUB HAS 30 MINUTES RUNNING TIME), THE CAREGIVER ENTERED THE ROOM TO FIND THE RESIDENT FACE DOWN IN THE WATER. THE CARE AID LIFTED THE RESIDENT FROM THE WATER USING THE SAFE LIFT, CALLED 911, AND BEGAN CPR UNTIL AMBULANCE PERSONNEL ARRIVED AND TOOK OVER. THER RESIDENT WAS TAKEN TO THE HOSPITAL. THE RESIDENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY TUB BATHING SYSTEM FNG ARJO HOSPITAL EQUIPMENT AB AHBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *