BEUDAMED
    FDA Adverse Event Summary report: N

    ATMOSAIR 9000AR MATTRESS

    MDR report key: 1221107 · Received October 22, 2008

    Report

    Report Number
    1221107
    Date Received
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    IKY
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WE RECENTLY REPLACED OUR EXISTING MATTRESSES WITH KCI ATMOSAIR MATTRESSES. OUR SERVICE TECHNICIAN DISCOVERED THAT THE BED EXIT ALARMS ON THE HILL ROM ADVANCE SERIES BEDS WERE NOT CONSISTENTLY WORKING WHEN THE HEAD OF BED WAS ELEVATED BETWEEN 35 AND 45 DEGREES. THE BOTTOM OF THE MATTRESS HAS A BLENDED/BUTYL RUBBER NON SLIP MATERIAL. WHEN THE BED IS IN THE POSITION DESCRIBED ABOVE AND A PATIENT GETS OUT OF BED THE MATTRESS GRIPS THE BED DECK AND DOES NOT RELEASE PRESSURE FROM THE BED EXIT SENSOR STRIPS. THIS PROBLEM DOES NOT EFFECT BEDS THAT USE THE BED SCALES TO SENSE WHEN THE PATIENT GETS OUT OF BED. KCI DID CONFIRM THE PROBLEM ON SITE. A DIFFERENT MATTRESS COVER WITH A VINYL BOTTOM WAS INSTALLED ON AN EXISTING MATTRESS AND TESTED. THE BED EXIT ALARM WORKED CONSISTENLY ON THE MATTRESS WITH THE VINYL COVER. THE PROBLEM WAS DISCOVERED PRIOR TO ANY PATIENT INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATMOSAIR 9000AR MATTRESS MATTRESS, FLOTATION THERAPY, NON-POWERED IKY KINETIC CONCEPTS, INC. 9000 *
    2 ADVANCE SERIES BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM COMPANY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *