BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIXED HEIGHT TUB

    MDR report key: 543481 · Received September 16, 2004

    Report

    Report Number
    9611530-2004-00029
    Event Type
    Death
    Date Received
    September 16, 2004
    Date of Event
    May 16, 2004
    Report Date
    August 26, 2004
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE STAFF HAD FILLED THE TUB AND PLACED THE RESIDENT IN THE TUB, SECURING THE HOLDING STRAP. THE TIMER ON THE TUB WAS SET FOR TWENTY MINUTES. THE STAFF DECIDED TO LET THE RESIDENT CONTINUE TO SOAK IN THE TUB AND TURNED TO REST THE TIMER. WHEN SHE TURNED BACK, THE RESIDENT HAD A SEIZURE AND HAD SLIPPED UNDER THE WATER. THE STAFF IMMEDIATELY GRABBED THE RESIDENT AND RELEASED THE STRAPS, REMOVED RESIDENT FROM THE TUB, AND STARTED ADMINISTERING FIRST AID AND CPR. THE RESIDENT WAS PLACED ON THE FLOOR IN THE NEAREST AND SAFEST PLACE. CPR WAS CONTINUED UNTIL THE EMT ARRIVED AND TOOK OVER. THE RESIDENT LATER PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED HEIGHT TUB BATHING SYSTEM ILJ ARJO HOSPITAL EQUIPMENT AB 07XXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death