BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREEZE SYSTEM

    MDR report key: 417611 · Received August 28, 2002

    Report

    Report Number
    417611
    Event Type
    Death
    Date Received
    August 28, 2002
    Date of Event
    August 22, 2002
    Report Date
    August 26, 2002
    Manufacturer
    HUNTLEIGH HEALTHCARE INC
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT APPROXIMATELTY 6:40AM THE RESIDENT WAS DISCOVERED ON THE RIGHT SIDE OF THE BED. THEIR KNEES WERE ON THE FLOOR, THE LOWER TORSO WAS BETWEEN THE SIDERAIL AND THE MATTRESS, THE UPPER TORSO, HEAD AND ARMS WERE ON THE MATTRESS. BOTH SIDERAILS WERE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE SYSTEM LOW AIRLOSS MATTRESS SYSTEM FNM HUNTLEIGH HEALTHCARE INC BREEZE *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death