BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIDIAN LOW AIR LOSS MATTRESS

    MDR report key: 6125813 · Received November 23, 2016

    Report

    Report Number
    3012316249-2016-00001
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    October 16, 2016
    Report Date
    November 23, 2016
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FOUND BY THE FACILITY AID ON (B)(6) 2016 WITH HER HEAD LODGED IN THE BED SIDE RAIL AND THE REST OF HER BODY ON THE FLOOR. THE PATIENT WAS FOUND DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775899 MERIDIAN LOW AIR LOSS MATTRESS AIR MATTRESS FNM EEZCARE MEDICAL CORP. 4800

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death GEL CUSHION| INVACARE FULL ELECTRIC BED WITH INVACARE BED RAILS| OVER THE BED TABLE| OXYGEN CONCENTRATOR