BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOURCE BED

    MDR report key: 1317538 · Received February 18, 2009

    Report

    Report Number
    MW5010015
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 18, 2009
    Manufacturer
    AMERICAN NATIONAL
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FOUND LYING ON METAL FRAME OF BED, DUE TO HALF OF THE POCKETS DEFLATED ON THE MATTRESS AND A "LEAK" WARNING LIGHT WAS ON, BUT NOT ALARMING. EVENT WAS CAUGHT BEFORE ANY INJURY TO PATIENT. BED/MATTRESS WAS RETURNED TO RENTAL COMPANY FOR REPAIR AND EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOURCE BED STIMULUS MATTRESS IKY AMERICAN NATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR