BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUAL CARE BY ALIMED

    MDR report key: 2940954 · Received May 22, 2006

    Report

    Report Number
    2940954
    Event Type
    Injury
    Date Received
    May 22, 2006
    Date of Event
    May 6, 2006
    Report Date
    May 19, 2006
    Manufacturer
    ALI MED, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BED SENSOR ALARM DID NOT ALARM TO NOTIFY STAFF OF BEING OUT OF BED WITHOUT HELP. RESIDENT FELL SUSTAINING A FRACTURED CLAVICLE. HAD ATIVAN 1 MG 30 MINUTES PRIOR TO FALL. USES OXYGEN THERAPY CONTINUOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUAL CARE BY ALIMED BED SENSOR ALARM KMI ALI MED, INC. 77141 528035

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization