BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE

    MDR report key: 374958 · Received January 25, 2002

    Report

    Report Number
    374958
    Event Type
    Death
    Date Received
    January 25, 2002
    Date of Event
    January 12, 2002
    Report Date
    January 25, 2002
    Manufacturer
    INVACARE CONTINUING CARE GROUP
    Product Code
    FNJ
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS RESIDENT WAS FOUND IN A SITTING POSITION ON THE FLOOR, PARALLEL TO AND ADJACENT TO THE LEFT SIDE OF THE BED, FACING THE FOOT OF THE BED. RIGHT ARM WAS ACROSS CHEST, LEFT ARM WAS EXTENDED TO THE SIDE. RESIDENT'S HEAD WAS WEDGED BETWEEN THE UPPER BED RAIL AND THE MATTRESS. CUASE OF DEATH: ACCIDENTAL MECHANICAL ASPHYXIATION. THE BED WAS IN THE LOWEST POSITION AND THE UPPER RAIL UP AT THE TIME OF THE INCIDENT. BED AND SIDERAILS IN USE AT THE TIME OF THE INCIDENT WERE INVACARE IH720-3M AND IH5820, PURCHASED 4 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE BED FNJ INVACARE CONTINUING CARE GROUP IH720-3M UNK
    2 INVACARE SIDERAIL FNJ INVACARE CONTINUING CARE GROUP IH5820 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death