BEUDAMED
    FDA Adverse Event Summary report: N

    ALTERNATING PRESSURE AIR FLOTATION MATTRESS

    MDR report key: 4211621 · Received October 29, 2014

    Report

    Report Number
    1531186-2014-05194
    Date Received
    October 29, 2014
    Report Date
    October 9, 2014
    Manufacturer
    GRAND HEALTHCARE CO., LTD.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT THEY WENT OUT TO SET UP THIS SYSTEM YESTERDAY AND THERE WAS A LEAK COMING FROM THE MATTRESS WHEN THEY WENT TO INSTALL IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692108 ALTERNATING PRESSURE AIR FLOTATION MATTRESS 880.5550 FNM GRAND HEALTHCARE CO., LTD. CG9702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other