BEUDAMED
    FDA Adverse Event Other Summary report: N

    KCI KENAIR III POWERED FLOTATION THERAPY BED

    MDR report key: 745828 · Received July 18, 2006

    Report

    Report Number
    MW1039778
    Event Type
    Other
    Date Received
    July 18, 2006
    Date of Event
    February 16, 2006
    Report Date
    July 18, 2006
    Manufacturer
    KCI
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONFUSED PT WITH HISTORY OF PULLING OUT IV TUBES AND FOLEY CATHETER WAS IN BILATERAL SOFT WRIST RESTRAINTS. HE WAS IN KCI KENAIR III POWERED FLOTATION THERAPY BED FOR MULTIPLE ESCHARS ON BOTH LEGS. HE SLID DOWN IN THE MIDDLE OF THE BED AND WAS FOUND SHORTLY AFTERWARD WITH HIS CHEST WEDGED IN BETWEEN THE MATTRESS AND THE SIDERAIL OF THE BED, WITH BOTH WRISTS STILL IN SOFT RESTRAINTS AND LEGS DOWN ( ZONE 4 ENTRAPMENT). NO IMPRINTS WERE FOUND ON FACE OR NECK; THERE WAS AN IMPRINT ON HIS CHEST FROM RAIL PRESSURE. NO EVIDENCE OF AIRWAY OBSTRUCTION, WAS NOT BLUE. THE PT WAS NOT RESPONSIVE AND WAS FOUND TO BE ASYSTOLIC. THE PT WAS DNR AND WAS NOT RESUSCITATED. AUTOPSY RESULTS WERE NOT CONSISTENT WITH CHEST ENTRAPMENT CONTRIBUTING TO EXPIRATION; RATHER, DEATH WAS DUE TO CARDIAC ARRHYTHMIA. THE ADVERSE REPORT BEING REPORTED IS THE ENTRAPMENT IN THE BED, AS THE DEATH WAS NOT RELATED TO THE ENTRAPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KCI KENAIR III POWERED FLOTATION THERAPY BED KCI KENAIR III BED INX KCI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other