BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIRST STEP SELECT

    MDR report key: 572936 · Received February 10, 2005

    Report

    Report Number
    572936
    Event Type
    Other
    Date Received
    February 10, 2005
    Date of Event
    January 2, 2005
    Report Date
    February 3, 2005
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    IKY
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIRST STEP SELECT MATTRESS PLACED ON HILL ROM BED. THE PATIENT WAS FOUND LAYING ON THE FLOOR NEXT TO THE BED. PATIENT WAS LAYING ON TOP OF THE FIRST STEP SELECT MATTRESS. APPARENTLY THE MATTRESS AND PATIENT SLID FROM THE BED. IT WAS NOTED THAT TWO SIDE RAILS WERE UP, BUT STAFF DID NOT RECORD NOR RECALL IF THE HEAD OF BED WAS RAISED. INVESTIGATION REVEALED THAT THE STRAPS FROM THE FIRST STEP SELECT MATTRESS OVERLAY HAD NOT BEEN HOOKED TO THE BED FRAME. STAFF WAS INSTRUCTED TO CHECK THE STRAPS ON MATTRESS TO ASSURE THAT THEY ARE SECURED TO THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST STEP SELECT MATTRESS OVERLAY IKY KINETIC CONCEPTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR