BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRMATT

    MDR report key: 1339663 · Received March 4, 2009

    Report

    Report Number
    1339663
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    December 2, 2008
    Report Date
    March 4, 2009
    Manufacturer
    EMERALD INTERNATIONAL HEALTH PRODUCTS INC
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING TRANSFERRED FROM SPECIAL OBESE BED TO DIAGNOSTIC TABLE. AIRMATT BEING PLACED UNDER THE PATIENT WHEN IT RIPPED ALONG THE SEAM OF THE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRMATT TRANSFER AND POSTIONING AIDE IKX EMERALD INTERNATIONAL HEALTH PRODUCTS INC AMT100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NO OTHER THERAPIES| NO OTHER THERAPIES