BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED CHECK, CLASSIC CHECK MODEL

    MDR report key: 1924002 · Received December 8, 2010

    Report

    Report Number
    MW5018534
    Event Type
    Death
    Date Received
    December 8, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BED CHECK CORPORATION
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS FOUND WITH LOWER BODY ON FLOOR AND UPPER BODY LEANING AGAINST BED. RESIDENT'S HEAD WAS ON BED ON LEFT SIDE IN BETWEEN MATTRESS AND SIDE RAIL. BED ALARM DID NOT SOUND AS HEAD WAS ON THE BED ALARM SENSOR. MEDICAL EXAMINER EXAMINED PT AND DETERMINED CAUSE OF DEATH TO BE ASPHYXIATION. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: HX OF FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED CHECK, CLASSIC CHECK MODEL BED ALARM KMI BED CHECK CORPORATION CLASSIC CHECK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death