BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTURY 60XR

    MDR report key: 543660 · Received September 16, 2004

    Report

    Report Number
    9611530-2004-00032
    Event Type
    Death
    Date Received
    September 16, 2004
    Date of Event
    May 22, 2004
    Report Date
    August 26, 2004
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT WAS ON THE SAF-LIFT AND PUT IN 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 MINUTE RUNNING TIME), THE CAREGIVER ENTERED TO ROOM TO FIND THE RESISDENT FACE DOWN IN THE WATER. THE CARE AID LIFTED THE RESIDENT FROM THE WATER USING THE SAF-LIFT, CALLED 911, AND BEGAN CPR UNTIL AMBULANCE PERSONNEL ARRIVED AND TOOK OVER. RESIDENT WAS TAKEN TO THE HOSP AND LATER PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY 60XR BATHING SYSTEM ILJ ARJO HOSPITAL EQUIPMENT AB AKBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death